Media 171675724527402700

21 March 2024
EMA/338956/2023 Rev. 4 Corr. 11

Human Medicines Division
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal

products, routes of administration, marketing authorisation holders or
applicants in the member states for medicinal products which have been
authorised or are pending approval based on studies performed at Synapse
Labs Pvt. Ltd., located in Kharadi, Pune, India
Referral under Article 31 of Directive 2001/83/EC
Procedure number: EMEA/H/A-31/1529
Please note that this draft Annex I may be updated during the procedure to reflect any amended
information on concerned products/MAHs & applicants.
1
30 April 2024
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

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Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union
© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.
Member Marketing
Pharmaceutical Route of
State in authorisaton Applicant Product name INN Strength
form administration
EEA holder
+pharma
Sitagliptin +pharma 100 mg Film-coated
Austria arzneimittel Sitagliptin 100 mg Oral use
Filmtabletten tablet
gmbh
+pharma
gmbh
+pharma
gmbh
+pharma Sitagliptin/Metforminhydrochlori
Sitagliptin/ 50 mg / Film-coated
Austria arzneimittel d +pharma 50 mg/1000 mg Oral use
metformin 1000 mg tablet
gmbh Filmtabletten
+pharma Sitagliptin/Metforminhydrochlori
Austria arzneimittel d +pharma 50 mg/850 mg Oral use
gmbh Filmtabletten
AOP Orphan
Tadalafil AOP 20 mg Film-coated
Austria Pharmaceutic Tadalafil 20 mg Oral use
als GmbH
Emulsion for
Propofol Baxter 1% MCT
Austria Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
Emulsion zur Injektion/Infusion
infusion
Emulsion for
Propofol Baxter 2% MCT
Austria Baxter B.V. Propofol 20 mg/ml injection/ Intravenous use
infusion
G.L. Pharma Film-coated
Austria Lanrektan 10 mg-Filmtabletten Tadalafil 10 mg Oral use
GmbH tablet
Austria Lanrektan 2,5 mg-Filmtabletten Tadalafil 2,5 mg Oral use
GmbH tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 2/248
Member Marketing
form administration
EEA holder

GmbH tablet
GmbH tablet
G.L. Pharma Sorafenib G.L. 400 mg- Film-coated
Austria Sorafenib 400 mg Oral use
GmbH Filmtabletten tablet
Austria Talrektan 10 mg Filmtabletten Tadalafil 10 mg Oral use
GmbH tablet
Austria Talrektan 2,5 mg Filmtabletten Tadalafil 2,5 mg Oral use
GmbH tablet
GmbH tablet
GmbH tablet
Genericon Sitagliptin Genericon 100 mg Film-coated
Austria Sitagliptin 100 mg Oral use
Pharma GmbH Filmtabletten tablet
Sitagliptin/Metforminhydrochlori
Genericon Sitagliptin/ 50 mg / Film-coated
Austria d Genericon 50 mg/1000 mg Oral use
Pharma GmbH metformin 1000 mg tablet
Filmtabletten
Sitagliptin/Metforminhydrochlori
Austria d Genericon 50 mg/850 mg Oral use
Filmtabletten
Annex I
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Member Marketing
form administration
EEA holder
Amlodipin/Valsartan/HCT Amlodipine/ 10 mg /
Holsten Film-coated
Austria Rivopharm 10 mg/160 mg/12,5 valsartan/ 160 mg / Oral use
Pharma tablet
mg Filmtabletten hydrochlorothiazide 12,5 mg
Holsten Film-coated
Austria Rivopharm 10 mg/160 mg/25 valsartan/ 160 mg / Oral use
Pharma tablet
mg Filmtabletten hydrochlorothiazide 25 mg
Holsten Film-coated
Austria Rivopharm 10 mg/320 mg/25 valsartan/ 320 mg / Oral use
Pharma tablet
mg Filmtabletten hydrochlorothiazide 25 mg
Amlodipin/Valsartan/HCT Amlodipine/ 5 mg / 160
Holsten Film-coated
Austria Rivopharm 5 mg/160 mg/12,5 valsartan/ mg / 12,5 Oral use
Pharma tablet
mg Filmtabletten hydrochlorothiazide mg
Amlodipin/Valsartan/HCT Amlodipine/ 5 mg / 160
Holsten Film-coated
Austria Rivopharm 5 mg/160 mg/25 valsartan/ mg / 25 Oral use
Pharma tablet
Opella
Racecadotril Opella Healthcare
Austria Healthcare Racecadotril 100 mg Capsule, hard Oral use
100 mg Hartkapsel
Austria GmbH
Pharmaselect
International
Austria Colchanova 0,5 mg Tabletten Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Pharmaselect
International
Austria Colchanova 1 mg Tabletten Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Darunavir Sandoz 800 mg – Film-coated
Austria Sandoz GmbH Darunavir 800 mg Oral use
Annex I
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Member Marketing
form administration
EEA holder
Efavirenz/ 600 mg /
Padviram 600 mg/200 mg/245 Film-coated
Austria Sandoz GmbH emtricitabine/ 200 mg / Oral use
mg - Filmtabletten tablet
tenofovir 245 mg
Sitagliptin Sandoz GmbH 100 Film-coated
Austria Sandoz GmbH Sitagliptin 100 mg Oral use
mg – Filmtabletten tablet
Sitagliptin Sandoz GmbH 25 mg Film-coated
– Filmtabletten tablet
Sitagliptin Sandoz GmbH 50 mg Film-coated
– Filmtabletten tablet
Sitagliptin/Metformin Sandoz
Austria Sandoz GmbH GmbH 50 mg/1000 mg – Oral use
Filmtabletten
Austria Sandoz GmbH GmbH 50 mg/850 mg – Oral use
Filmtabletten
Sorafenib Sandoz 400 mg - Film-coated
Austria Sandoz GmbH Sorafenib 400 mg Oral use
Stada Abacavir/Lamivudin Stada 600 Abacavir/ 600 mg / Film-coated
Austria Oral use
Arzneimittel mg/300 mg Filmtabletten lamivudine 300 mg tablet
Stada Darunavir STADA 800 mg Film-coated
Austria Darunavir 800 mg Oral use
Arzneimittel Filmtabletten tablet
Stada Deferasirox STADA 900 mg Film-coated
Austria Deferasirox 900 mg Oral use
600 mg/
Stada Efatriten 600 mg/200 mg/245 Film-coated
Austria Efavirenz 200 mg/ Oral use
Arzneimittel mg Filmtabletten tablet
245 mg
Stada Lacosamid STADA 100 mg Film-coated
Austria Lacosamide 100 mg Oral use
Annex I
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Member Marketing
form administration
EEA holder

Stada Posaconazol STADA 40 mg/ml
Austria Posaconazole 40 mg/ml Oral suspension Oral use
Arzneimittel Suspension zum Einnehmen
Sunitinib Bluefish 12,5 mg
Austria Bluefish Sunitinib 12,5 mg Capsule, hard Oral use
Hartkapseln
Sunitinib Bluefish 25 mg
Austria Bluefish Sunitinib 25 mg Capsule, hard Oral use
Hartkapseln
Sunitinib Bluefish 50 mg
Austria Bluefish Sunitinib 50 mg Capsule, hard Oral use
Hartkapseln
Eltrombopag Devatis 12,5 mg Film-coated
Austria Devatis GmbH Eltrombopag 12,5 mg Oral use
Eltrombopag Devatis 25 mg Film-coated
Austria Devatis GmbH Eltrombopag 25 mg Oral use
Pharos
Pharmaceutical Nilotinib PharOS 150 mg
Austria Nilotinib 150 mg Capsule, hard Oral use
Oriented Hartkapseln
Services Ltd.
Annex I
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Member Marketing
form administration
EEA holder
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Pharmaceutical Nilotinib Viatris 150 mg
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Pharmaceutical Nilotinib Zentiva 150 mg
Services Ltd.
Pharos
Services Ltd.
Annex I
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Member Marketing
form administration
EEA holder
Aurobindo Leflunomide AB - 10 mg - Film- Film-coated

Belgium Leflunomide 10 mg Oral use
N.V. coated tablet tablet
Olanzapin AB 5 mg
Aurobindo Orodispersible
Belgium orodispergeerbare Olanzapine 5 mg Oral use
N.V. tablet
tabletten
Belgium Olanzapina Aurobindo xx mg Olanzapine Oral use
N.V. 10 mg tablet
Belgium Olanzapina Aurobindo xx mg Olanzapine 15 mg Oral use
N.V. tablet
Belgium Olanzapina Aurobindo xx mg Olanzapine 20 mg Oral use
N.V. tablet
Aurobindo
Belgium Olanzapine AB 10 mg tabletten Olanzapine 10 mg Tablet Oral use
N.V.
Aurobindo
N.V.
Aurobindo
Belgium Olanzapine AB 2.5 mg tabletten Olanzapine 2,5 mg Tablet Oral use
N.V.
Aurobindo
N.V.
Aurobindo
Belgium Olanzapine AB 5 mg tabletten Olanzapine Tablet Oral use
N.V. 5 mg
Aurobindo
Belgium Olanzapine AB 7.5 mg tabletten Olanzapine 7,5 mg Tablet Oral use
N.V.
Aurobindo Bosentan AB - 125 mg - Film- Film-coated
Belgium Bosentan 125 mg Oral use
Pharma B.V. coated tablet tablet
Aurobindo Bosentan AB - 62.5 mg - Film- Film-coated
Belgium Bosentan 62,5 mg Oral use
Pharma B.V. coated tablet tablet
Annex I
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Member Marketing
form administration
EEA holder
Brown & Burk

Belgium Lymecycline Brown & Burk Lymecycline 300 mg Capsule, hard Oral use
IR Limited
EG
Erlotinib EG - 100 mg - Film- Film-coated
Belgium (Eurogenerics Erlotinib 100 mg Oral use
coated tablet tablet
) NV
EG
) NV
EG
) NV
EG
) NV
EG
Lacosamide EG - 100 mg - Film-coated
Belgium (Eurogenerics Lacosamide 100 mg Oral use
Film-coated tablet tablet
) NV
EG
) NV
EG
) NV
EG
Lacosamide EG - 50 mg - Film- Film-coated
) NV
Annex I
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Member Marketing
form administration
EEA holder
EG
Sorafenib Eurogenerics - 400 Film-coated
Belgium (Eurogenerics Sorafenib 400 mg Oral use
mg - Film-coated tablet tablet
) NV
EG
Tadalafil Eurogenerics - 10 mg - Film-coated
Belgium (Eurogenerics Tadalafil 10 mg Oral use
) NV
EG
Tadalafil Eurogenerics - 2.5 mg Film-coated
Belgium (Eurogenerics Tadalafil 2,5 mg Oral use
- Film-coated tablet tablet
) NV
EG
) NV
EG
) NV
Pharmaselect
International Colchicin Pharmaselect - 0.5 mg Film-coated
Belgium Colchicine 0,5 mg Oral use
Beteiligungs - Tablet tablet
GmbH
Pharmaselect
International Colchicin Pharmaselect - 1 mg - Film-coated
Belgium Colchicine 1 mg Oral use
Beteiligungs Tablet tablet
GmbH
Sandoz - SA- Darunavir Sandoz - 600 mg - Film-coated
Belgium Darunavir 600 mg Oral use
NV - Belgium Film-coated tablet tablet
Sandoz - SA- Darunavir Sandoz - 800 mg - Film-coated
Belgium Darunavir 800 mg Oral use
Annex I
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Member Marketing
form administration
EEA holder
Sandoz - SA- Erlotinib Sandoz - 100 mg - Film-coated

Belgium Erlotinib 100 mg Oral use
Sandoz - SA- Erlotinib Sandoz - 150 mg - Film-coated
Sandoz - SA- Erlotinib Sandoz - 25 mg - Film- Film-coated
NV - Belgium coated tablet tablet
Sandoz - SA- Sorafenib Sandoz - 400 mg - Film-coated
Belgium Sorafenib 400 mg Oral use
Sitagliptin Sandoz GmbH - 100 Film-coated
Belgium Sandoz GmbH Sitagliptin 100 mg Oral use
Belgium Sandoz GmbH GmbH - 50 mg - 1000 mg - Oral use
Film-coated tablet
Belgium Sandoz GmbH GmbH - 50 mg - 850 mg - Film- Oral use
coated tablet
Generis
Teriflunomide AB - 14 mg - Film-coated
Belgium Farmacêutica, Teriflunomide 14 mg Oral use
S.A.
Generis
Film-coated
Belgium Farmacêutica, Trazodona Generis Phar Trazodone 100 mg Oral use
tablet
S.A.
Annex I
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Member Marketing
form administration
EEA holder
Kappler
Belgium Pharma Betahistin "Kappler" Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
Pharos
Pharmaceutical Nilotinib PharOS 150 mg, harde
Belgium Nilotinib 150 mg Capsule, hard Oral use
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Nilotinib Viatris 150 mg, harde
Belgium Viatris Limited Nilotinib 150 mg Capsule, hard Oral use
capsules
capsules
capsules
Annex I
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Member Marketing
form administration
EEA holder
Amlodipine/ 5 mg / 160
Alkaloid - INT Amlodipine/Valsartan/Hydrochlo Film-coated
Bulgaria valsartan/ mg / 12,5 Oral use
d.o.o. rothiazide Alkaloid-INT tablet
hydrochlorothiazide mg
Amlodipine/ 10 mg /
Bulgaria valsartan/ 160 mg / Oral use
hydrochlorothiazide 25 mg
Amlodipine/ 10 mg /
hydrochlorothiazide 12,5 mg
Amlodipine/ 10 mg /
Amlodipine/ 10 mg /
Alkaloid - INT Film-coated
Bulgaria Lacosamide Alkaloid-INT Lacosamide 50 mg Oral use
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
Bulgaria Gerocilan Tadalafil 10 mg Oral use
GmbH tablet
GmbH tablet
Annex I
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Member Marketing
form administration
EEA holder

Bulgaria Gerocilan Tadalafil 2,5 mg Oral use
GmbH tablet
GmbH tablet
Pharmacons Film-coated
Bulgaria Amvalcon-Co valsartan/ mg / 12,5 Oral use
AD tablet
Pharmacons
Bulgaria Olanzacon Olanzapine 10 mg Tablet Oral use
AD
Bulgaria Tadalacon Tadalafil 10 mg Oral use
AD tablet
Bulgaria Tadalacon Tadalafil 20 mg Oral use
AD tablet
Pharmacons Vildagliptin/ 50 mg / Film-coated
Bulgaria Vildacon-Met Oral use
AD metformin 1000 mg tablet
RIA Generics
Bulgaria Colchicine Ria Colchicine 0,5 mg Tablet Oral use
Limited
RIA Generics
Bulgaria Colchicine Ria Colchicine 1 mg Tablet Oral use
Limited
Film-coated
Bulgaria Sandoz d.d. Erlotinib Sandoz Erlotinib 100 mg Oral use
tablet
Film-coated
Bulgaria Sandoz d.d. Erlotinib Sandoz Erlotinib 150 mg Oral use
tablet
Film-coated
Bulgaria Teva B.V. Deferasirox Teva Deferasirox 900 mg Oral use
tablet
Film-coated
Bulgaria Zentiva k.s. Asbima HCT valsartan/ mg / 12,5 Oral use
tablet
Annex I
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Member Marketing
form administration
EEA holder
Amlodipine/ 10 mg /
Film-coated
Bulgaria Zentiva k.s. Asbima HCT valsartan/ 160 mg / Oral use
tablet
Pharmascience
Bulgaria International Nilotinib Pharmascience Nilotinib 150 mg Capsule, hard Oral use
Limited
Pharmascience
Bulgaria International Nilotinib Pharmascience Nilotinib 200 mg Capsule, hard Oral use
Limited
Bulgaria Viatris Limited Nilotinib Viatris Nilotinib 150 mg Capsule, hard Oral use
Bulgaria Viatris Limited Nilotinib Viatris Nilotinib 200 mg Capsule, hard Oral use
Bulgaria Zentiva k.s. Nilotinib Zentiva Nilotinib 150 mg Capsule, hard Oral use
Bulgaria Zentiva k.s. Nilotinib Zentiva Nilotinib 200 mg Capsule, hard Oral use
Amlodipine/ 10 mg /
Alkaloid - INT Awerkano 10 mg/160 mg/12,5 Film-coated
Croatia valsartan/ 160 mg / Oral use
d.o.o. mg filmom obložene tablete tablet
Amlodipine/ 10 mg /
Alkaloid - INT Awerkano 10 mg/160 mg/25 Film-coated
Amlodipine/ 10 mg /
Alkaloid - INT Awerkano 10 mg/320 mg/25 Film-coated
Alkaloid - INT Awerkano 5 mg/160 mg/12,5 Film-coated
Croatia valsartan/ mg / 12,5 Oral use
Alkaloid - INT Awerkano 5 mg/160 mg/25 mg Film-coated
Croatia valsartan/ mg / 25 Oral use
d.o.o. filmom obložene tablete tablet
Annex I
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Member Marketing
form administration
EEA holder
Alkaloid - INT Losmorid 100 mg filmom Film-coated

Croatia Lacosamide 100 mg Oral use
d.o.o. obložene tablete tablet
AOP Orphan
Tadalafil AOP 20 mg filmom Film-coated
Croatia Pharmaceutic Tadalafil 20 mg Oral use
obložene tablete tablet
als GmbH
Belupo lijekovi
Condias Combi 50 mg/1000 mg Sitagliptin/ 50 mg/ Film-coated
Croatia i kozmetika, Oral use
filmom obložene tablete metformin 1000 mg tablet
d.d.
Belupo lijekovi
Condias Combi 50 mg/850 mg Sitagliptin/ 50 mg/ Film-coated
Croatia i kozmetika, Oral use
filmom obložene tablete metformin 850 mg tablet
d.d.
Belupo lijekovi
Midza 100 mg filmom obložene Film-coated
Croatia i kozmetika, Lacosamide 100 mg Oral use
tablete tablet
d.d.
Belupo lijekovi
tablete tablet
d.d.
Belupo lijekovi
tablete tablet
d.d.
Annex I
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Member Marketing
form administration
EEA holder
Belupo lijekovi
tablete tablet
d.d.
Croatia Farmex d.o.o. Nibufar 12,5 mg tvrde kapsule Sunitinib 12,5 mg Capsule, hard Oral use
Croatia Farmex d.o.o. Nibufar 25 mg tvrde kapsule Sunitinib 25 mg Capsule, hard Oral use
Croatia Farmex d.o.o. Nibufar 50 mg tvrde kapsule Sunitinib 50 mg Capsule, hard Oral use
Amlodipin/valsartan/hidrokloroti
Amlodipine/ 10 mg /
Genepharm azid Genepharm 10 mg/160 Film-coated
S.A. mg/12,5 mg filmom obložene tablet
tablete
Amlodipine/ 10 mg /
S.A. mg/25 mg filmom obložene tablet
tablete
Amlodipine/ 10 mg /
tablete
Croatia valsartan/ mg / 12,5 Oral use
S.A. mg/12,5 mg filmom obložene tablet
tablete
Croatia valsartan/ mg / 25 Oral use
tablete
Annex I
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Member Marketing
form administration
EEA holder
Sitagliptin/metforminklorid
Croatia Genericon 50 mg/1000 mg Oral use
filmom obložene tablete
Sitagliptin/metforminklorid
Croatia Genericon 50 mg/850 mg Oral use
filmom obložene tablete
Jadran
Magnolicomb HCT Amlodipine/ 10 mg /
Galenski Film-coated
Croatia 10mg/160mg/12,5mg filmom valsartan/ 160 mg / Oral use
laboratorij tablet
obložene tablete hydrochlorothiazide 12,5 mg
d.d.
Jadran
Magnolicomb HCT Amlodipine/ 5 mg / 160
Croatia 5mg/160mg/25mg filmom valsartan/ mg / 25 Oral use
laboratorij tablet
obložene tablete hydrochlorothiazide mg
d.d.
Jadran
Magnolicomb HCT Amlodipine/ 5 mg / 160
Croatia 5mg/160mg/12,5mg filmom valsartan/ mg / 12,5 Oral use
laboratorij tablet
obložene tablete hydrochlorothiazide mg
d.d.
Mylan
Erlotinib Mylan 150 mg filmom Film-coated
Croatia Pharmaceutic Erlotinib 150 mg Oral use
als Limited
PharmaS Erlotinib PharmaS 150 mg Film-coated
Croatia Erlotinib 150 mg Oral use
d.o.o. filmom obložene tablete tablet
Pharmaselect
International
Croatia Colcamexx 0,5 mg tablete Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Annex I
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Member Marketing
form administration
EEA holder
Pharmaselect
International
Croatia Colcamexx 1 mg tablete Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Erlotinib Remedica 150 mg Film-coated
Croatia Remedica Ltd Erlotinib 150 mg Oral use
filmom obložene tablete tablet
Darunavir Sandoz 800 mg Film-coated
Croatia Sandoz d.o.o. Darunavir 800 mg Oral use
Sorafenib Sandoz 400 mg Film-coated
Croatia Sandoz d.o.o. Sorafenib 400 mg Oral use
Efavirenz/ 600 mg/
Emtenef 600 mg/200 mg/245 Film-coated
Croatia Stada d.o.o. emtricitabine/ 200 mg/ Oral use
mg filmom obložene tablete tablet
tenofovir 245 mg
Sorafenib Stada 400 mg filmom Film-coated
Croatia Stada d.o.o. Sorafenib 400 mg Oral use
Umedica
Deferasiroks Umedica 180 mg Film-coated
Croatia Netherlands Deferasirox 180 mg Oral use
B.V.
Umedica
B.V.
Umedica
B.V.
Belupo lijekovi
Gitas 100 mg filmom obložene Film-coated
Croatia i kozmetika Sitagliptin 100 mg Oral use
tablete tablet
d.d.
Annex I
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Member Marketing
form administration
EEA holder
Belupo lijekovi
tablete tablet
d.d.
Belupo lijekovi
tablete tablet
d.d.
Elpen
Raupresil 375 mg tablete s Prolonged-
Croatia Pharmaceutical Ranolazine 375 mg Oral use
produljenim oslobađanjem release tablet
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Ranzolva 375 mg tablete s Prolonged-
Croatia Hexal AG Ranolazine 375 mg Oral use
Pilokarpin hidroklorid 5 mg
Croatia Milstein C.V. Pilocarpine 5 mg Tablet Oral use
tablete
Pharos
Pharmaceutical Nilotinib Pharmascience 150 mg
Croatia Nilotinib 150 mg Capsule, hard Oral use
Oriented tvrde kapsule
Services Ltd.
Annex I
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Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical Nilotinib Pharmascience 200 mg
Oriented tvrde kapsule
Services Ltd.
Pharos
Pharmaceutical Nilotinib PharOS 150 mg tvrde
Oriented kapsule
Services Ltd.
Pharos
Oriented kapsule
Services Ltd.
Pharos
Oriented kapsule
Services Ltd.
Pharos
Oriented kapsule
Services Ltd.
Pharos
Oriented kapsule
Services Ltd.
ViaremBlu 100 mg filmom Film-coated
Croatia Remedica Ltd. Sildenafil 100 mg Oral use
Annex I
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Nilotinib Zentiva 150 mg tvrde
Croatia Zentiva k.s. Nilotinib 150 mg Capsule, hard Oral use
kapsule
Nilotinib Zentiva 200 mg tvrde
Croatia Zentiva k.s. Nilotinib 200 mg Capsule, hard Oral use
kapsule
Accord
Iviverz tablet, film-coated 600 Abacavir/ 600 mg/ Film-coated
Cyprus Healthcare Oral use
mg/300 mg lamivudine 300 mg tablet
S.L.U
Aurobindo
Pharma Bosentan Aurobindo tablet, Film-coated
Cyprus Bosentan 125 mg Oral use
(Malta) film-coated 125mg tablet
Limited
Aurobindo
Pharma Bosentan Aurobindo tablet, Film-coated
Cyprus Bosentan 62,5 mg Oral use
(Malta) film-coated 62,5mg tablet
Limited
Aurobindo
Pharma Olanzapine Aurobindo 10 mg
Cyprus Olanzapine 10 mg Tablet Oral use
(Malta) δισκία
Limited
Aurobindo
Cyprus Olanzapine Tablet Oral use
(Malta) δισκία 5 mg
Limited
Elpen Amlodipine/ 5 mg / 160
Amlodipin/Valsartan/Hydrochlor Film-coated
Cyprus Pharmaceutic valsartan/ mg / 12,5 Oral use
thiazid "Elpen" tablet
al Co. Inc hydrochlorothiazide mg
Annex I
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Elpen Amlodipine/ 10 mg /
Cyprus Pharmaceutic valsartan/ 160 mg / Oral use
al Co. Inc hydrochlorothiazide 25 mg
Elpen Amlodipine/ 10 mg /
Cyprus Pharmaceutic valsartan/ 320 mg / Oral use
al Co. Inc hydrochlorothiazide 25 mg
Elpen Amlodipine/
Amlodipin/Valsartan/Hydrochlor 5 mg/ 160 Film-coated
Cyprus Pharmaceutic valsartan/ Oral use
thiazid "Elpen" mg/ 25 mg tablet
al Co. Inc hydrochlorothiazide
Elpen Amlodipine/ 10 mg/ 160
Cyprus Pharmaceutic valsartan/ mg/ 12,5 Oral use
Elpen
Cyprus Pharmaceutic Padlas tablet 50 mg Vildagliptin 50 mg Tablet Oral use
al Co. Inc
Amlodipine/Valsartan/Hydrochlo
Amlodipine/ 10 mg/ 160
Genepharm rothiazide Genepharm tablet, Film-coated
Cyprus valsartan/ mg/ 12,5 Oral use
S.A. film-coated tablet
10mg/160mg/12.5mg
Amlodipine/Valsartan/Hydrochlo Amlodipine/
Genepharm 10 mg/ 160 Film-coated
Cyprus rothiazide Genepharm tablet, valsartan/ Oral use
S.A. mg/ 25 mg tablet
film-coated 10mg/160mg/25mg hydrochlorothiazide
Amlodipine/
Genepharm rothiazide Genepharm tablet, 10 mg/ 320 Film-coated
Cyprus valsartan/ Oral use
S.A. film-coated mg/ 25 mg tablet
hydrochlorothiazide
10mg/320mg/12.5mg
Annex I
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Member Marketing
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Genepharm rothiazide Genepharm tablet, Film-coated
Cyprus valsartan/ mg/ 12,5 Oral use
S.A. film-coated tablet
5mg/160mg/12.5mg
Amlodipine/Valsartan/Hydrochlo Amlodipine/
Genepharm 5 mg/ 160 Film-coated
Cyprus rothiazide Genepharm tablet, valsartan/ Oral use
S.A. mg/ 25 mg tablet
film-coated 5mg/160mg/25mg hydrochlorothiazide
Genepharm Lacosamide/Genepharm tablet, Film-coated
Cyprus Lacosamide 100 mg Oral use
S.A. film-coated 100 mg tablet
Genepharm Radicut tablet, film-coated 50 Vildagliptin/ 50 mg/ Film-coated
Cyprus Oral use
S.A. mg/1000 mg metformin 1000 mg tablet
Genepharm Radicut tablet, film-coated 50 Vildagliptin/ 50 mg/ Film-coated
Cyprus Oral use
S.A. mg/850 mg metformin 850 mg tablet
Atazanavir Remedica Capsule,
Cyprus Remedica Ltd Atazanavir 100 mg Capsule, hard Oral use
hard 100mg
hard 150mg
hard 200mg
hard 300mg
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 24/248
Member Marketing
form administration
EEA holder
Erlotinib Remedica tablet, film- Film-coated

Cyprus Remedica Ltd Erlotinib 100 mg Oral use
coated 100 mg tablet
coated 150 mg tablet
coated 25 mg tablet
coated 50 mg tablet
Abacavir/ 600 mg / Film-coated
Cyprus Remedica Ltd Kivala tablet, film-coated Oral use
lamivudine 300 mg tablet
Laprem tablet, film-coated 250 Film-coated
Cyprus Remedica Ltd Lapatinib 250 mg Oral use
mg tablet
Rexanib tablet, film-coated 400 Film-coated
Cyprus Remedica Ltd Sorafenib 400 mg Oral use
mg tablet
Rezavir tablet, film-coated 150 Film-coated
Cyprus Remedica Ltd Darunavir 150 mg Oral use
mg tablet
mg tablet
mg tablet
mg tablet
mg tablet
mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 25/248
Member Marketing
form administration
EEA holder
Efavirenz/ 600 mg /
Trinistem tablet, film-coated Film-coated
Cyprus Remedica Ltd emtricitabine/ 200 mg / Oral use
600 mg/200 mg/245 mg tablet
tenofovir 245 mg
Sapiens
Pharmaceutic Genement tablet, film-coated Film-coated
Cyprus Tadalafil 20 mg Oral use
als Ltd, 20 mg tablet
Lemesos
Sapiens
Pharmaceutic Genement tablet, film-coated 5 Film-coated
Cyprus Tadalafil 5 mg Oral use
als Ltd, mg tablet
Lemesos
Cyprus Viatris Limited Tutecvi tablet 50 mg Vildagliptin 50 mg Tablet Oral use
Win Medica Combipress tablet, film-coated Amlodipine/ 10 mg/ 150 Film-coated
Cyprus Oral use
S.A. 10mg/150mg irbesartan mg tablet
Cyprus Oral use
Cyprus Oral use
Cyprus Oral use
Win Medica Retaform tablet, prolonged- Prolonged-
Cyprus Metformin 1000 mg Oral use
S.A. release 1000 mg release tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 26/248
Member Marketing
form administration
EEA holder
Elpen
Ranolazine Elpen tablet, Prolonged-
Cyprus Pharmaceutical Ranolazine 375 mg Oral use
prolonged-release 375 mg release tablet
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Raxala tablet, prolonged- Prolonged-
release 375 mg release tablet
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Pharos
Pharmaceutical Nilotinib Pharos capsule, hard
Cyprus Nilotinib 150 mg Capsule, hard Oral use
Oriented 150 mg
Services Ltd.
Pharos
Oriented 200 mg
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 27/248
Member Marketing
form administration
EEA holder
Pharos
Oriented 50 mg
Services Ltd.
Pharos
Pharmaceutical Nilotinib Viatris capsule, hard
Oriented 150 mg
Services Ltd.
Pharos
Pharmaceutical Nilotinib Viatris capsule, hard
Oriented 200 mg
Services Ltd.
Pharos
Efavirenz/ 600 mg/
Pharmaceutical Padviram tablet, film-coated Film-coated
Cyprus emtricitabine/ 200 mg/ Oral use
Oriented 600 mg/200 mg/245 mg tablet
tenofovir 245 mg
Services Ltd.
Viaremblu tablet, film-coated Film-coated
Cyprus Remedica Ltd. Sildenafil 100 mg Oral use
100 mg tablet
25 mg tablet
50 mg tablet
Cyprus Remedica Ltd. Zestaval tablet 400 mg Albendazole 400 mg Tablet Oral use
Sandoz Erlotinib Sandoz tablet, film- Film-coated
Cyprus Erlotinib 150 mg Oral use
Hungaria KFT. coated 150 mg tablet
Sapiens
Cyprus Pharmaceutical Aglimon tablet 50mg Vildagliptin 50 mg Tablet Oral use
s Ltd
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 28/248
Member Marketing
form administration
EEA holder
Sapiens
Sunitinib Sapiens capsule, hard
Cyprus Pharmaceutical Sunitinib 12,5 mg Capsule, hard Oral use
12.5 mg
s Ltd
Sapiens
Cyprus Pharmaceutical Sunitinib 25 mg Capsule, hard Oral use
25 mg
s Ltd
Sapiens
Cyprus Pharmaceutical Sunitinib 37,5 mg Capsule, hard Oral use
37.5 mg
s Ltd
Sapiens
Cyprus Pharmaceutical Sunitinib 50 mg Capsule, hard Oral use
50 mg
s Ltd
+pharma
Czech Film-coated
arzneimittel Sitagliptin +pharma Sitagliptin 25 mg Oral use
Republic tablet
gmbh
+pharma
Czech Film-coated
Republic tablet
gmbh
+pharma
Czech Film-coated
Republic tablet
gmbh
+pharma
Czech Sitagliptin/ 50 mg/ Film-coated
arzneimittel Sitagliptin/Metformin +pharma Oral use
Republic metformin 850 mg tablet
gmbh
+pharma
arzneimittel Sitagliptin/Metformin +pharma Oral use
gmbh
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 29/248
Member Marketing
form administration
EEA holder
AOP Orphan
Czech Film-coated
Pharmaceutic Tadalafil AOP Tadalafil 20 mg Oral use
Republic tablet
als GmbH
ARDEZ
Czech Film-coated
Pharma, spol. Laramo Lacosamide 50 mg Oral use
Republic tablet
s r.o.
ARDEZ
Czech Film-coated
Republic tablet
s r.o.
ARDEZ
Czech Film-coated
Republic tablet
s r.o.
ARDEZ
Czech Film-coated
Republic tablet
s r.o.
Ardez
Czech Film-coated
Pharma, spol. Tadard Tadalafil 5 mg Oral use
Republic tablet
s r.o.
Ardez
Czech Film-coated
Pharma, spol. Tadard Tadalafil 20 mg Oral use
Republic tablet
s r.o.
Emulsion for
Czech
Baxter B.V. Anesia Propofol 10 mg/ml injection/ Intravenous use
Republic
infusion
Emulsion for
Czech
Baxter B.V. Anesia Propofol 20 mg/ml injection/ Intravenous use
Republic
infusion
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 30/248
Member Marketing
form administration
EEA holder
Belupo
Czech Lijekovi I Sitagliptin/ 50 mg/ Film-coated
Condias Combi Oral use
Republic Kozmetika metformin 850 mg tablet
d.d.
Belupo
Czech Lijekovi I Sitagliptin/ 50 mg/ Film-coated
Condias Combi Oral use
Republic Kozmetika metformin 1000 mg tablet
d.d.
Belupo lijekovi
Czech Film-coated
i kozmetika, Midza Lacosamide 50 mg Oral use
Republic tablet
d.d.
Belupo lijekovi
Czech Film-coated
Republic tablet
d.d.
Belupo lijekovi
Czech Film-coated
Republic tablet
d.d.
Belupo lijekovi
Czech Film-coated
Republic tablet
d.d.
Belupo lijekovi
Czech Film-coated
i kozmetika, Tadalafil Belupo Tadalafil 20 mg Oral use
Republic tablet
d.d.
Czech Dr. Max
Loperamid Dr.Max Loperamide 2 mg Capsule, hard Oral use
Republic Pharma s.r.o.
Farmak
Czech Film-coated
International Tadalafil FMK Tadalafil 2,5 mg Oral use
Republic tablet
Sp.z.o.o.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 31/248
Member Marketing
form administration
EEA holder
Farmak
Czech Film-coated
International Tadalafil FMK Tadalafil 5 mg Oral use
Republic tablet
Sp.z.o.o.
Farmak
Czech Film-coated
Republic tablet
Sp.z.o.o.
Farmak
Czech Film-coated
Republic tablet
Sp.z.o.o.
Czech Film-coated
Heaton k.s. Anau Sitagliptin 100 mg Oral use
Republic tablet
Heaton k.s. Sipactimet Oral use
Heaton k.s. Sipactimet Oral use
Neuraxpharm
Czech Film-coated
Bohemia Arkvimma Lacosamide 50 mg Oral use
Republic tablet
s.r.o.
Neuraxpharm
Czech Film-coated
Republic tablet
s.r.o.
Neuraxpharm
Czech Film-coated
Republic tablet
s.r.o.
Neuraxpharm
Czech Film-coated
Republic tablet
s.r.o.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 32/248
Member Marketing
form administration
EEA holder
Neuraxpharm
Czech Modified-release
Bohemia Azoneurax Trazodone 75 mg Oral use
Republic tablet
s.r.o.
Neuraxpharm
Czech Modified-release
Bohemia Azoneurax Trazodone 150 mg Oral use
Republic tablet
s.r.o.
Czech Novatin Prolonged-
Zexitor Metformin 500 mg Oral use
Republic Limited release tablet
Opella
Czech
Healthcare Enditril Racecadotril 100 mg Capsule, hard Oral use
Republic
Czech s.r.o.
Pharmaselect
Czech International
Colchicine Pharmaselect Colchicine 0,5 mg Tablet Oral use
Republic Beteiligungs
GmbH
Pharmaselect
Czech International
Colchicine Pharmaselect Colchicine 1 mg Tablet Oral use
Republic Beteiligungs
GmbH
Czech Film-coated
Sandoz GmbH Sitagliptin Sandoz GmbH Sitagliptin 100 mg Oral use
Republic tablet
Czech Sitagliptin/Metformin Sandoz Sitagliptin/ 50 mg/ Film-coated
Sandoz GmbH Oral use
Republic GmbH metformin 850 mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 33/248
Member Marketing
form administration
EEA holder
Czech Sitagliptin/Metformin Sandoz Sitagliptin/ 50 mg/ Film-coated

Sandoz GmbH Oral use
Republic GmbH metformin 1000 mg tablet
Czech Film-coated
Sandoz s.r.o. Sorafenib Sandoz Sorafenib 400 mg Oral use
Republic tablet
Stada
Czech Film-coated
Arzneimittel Sorafenib Stada Sorafenib 400 mg Oral use
Republic tablet
AG
Umedica
Czech Film-coated
Netherlands Pirfenidone Umedica Pirfenidone 267 mg Oral use
Republic tablet
B.V.
Umedica
Czech Film-coated
Netherlands Pirfenidone Umedica Pirfenidone 801 mg Oral use
Republic tablet
B.V.
Umedica
Czech Prolonged-
Netherlands Ranolazine Umedica Ranolazine 375 mg Oral use
Republic release tablet
B.V.
Umedica
Czech Prolonged-
B.V.
Umedica
Czech Prolonged-
B.V.
Czech
Viatris Limited Tutecvi Vildagliptin 50 mg Tablet Oral use
Republic
Czech
Vipharm S.A. Anvildis Vildagliptin 50 mg Tablet Oral use
Republic
Czech Win Medica Amlodipine/ 5 mg/ 150 Film-coated
Combipres Oral use
Republic S.A. irbesartan mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 34/248
Member Marketing
form administration
EEA holder

Combipres Oral use
Combipres Oral use
Combipres Oral use
Belupo Lijekovi
Czech Film-coated
I Kozmetika Condias Sitagliptin 25 mg Oral use
Republic tablet
d.d.
Belupo Lijekovi
Czech Film-coated
Republic tablet
d.d.
Belupo Lijekovi
Czech Film-coated
Republic tablet
d.d.
Kappler
Czech
Pharma Betahistin Kappler Betahistine 8 mg Tablet Oral use
Republic
Consult GmbH
Kappler
Czech
Republic
Consult GmbH
Kappler
Czech
Republic
Consult GmbH
Czech
Medreg s.r.o. Betahistine Medreg Betahistine 16 mg Tablet Oral use
Republic
Czech
Medreg s.r.o. Betahistine Medreg Betahistine 24 mg Tablet Oral use
Republic
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 35/248
Member Marketing
form administration
EEA holder
Czech Nutra Essential

Ibuprofen Nutra Essential Ibuprofen 400 mg Capsule, soft Oral use
Republic OTC, S.L.
Pharos
Czech Pharmaceutical
Nilotinib Pharos Nilotinib 50 mg Capsule, hard Oral use
Republic Oriented
Services Ltd.
Pharos
Republic Oriented
Services Ltd.
Pharos
Republic Oriented
Services Ltd.
Pharos
Nilotinib Viatris Nilotinib 150 mg Capsule, hard Oral use
Republic Oriented
Services Ltd.
Pharos
Nilotinib Viatris Nilotinib 200 mg Capsule, hard Oral use
Republic Oriented
Services Ltd.
Pharos
Nilotinib Zentiva Nilotinib 150 mg Capsule, hard Oral use
Republic Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 36/248
Member Marketing
form administration
EEA holder
Pharos
Nilotinib Zentiva Nilotinib 200 mg Capsule, hard Oral use
Republic Oriented
Services Ltd.
Rontis Hellas
Czech Medical And
Tadax Tadalafil 5 mg Chewable tablet Oral use
Republic Pharmaceutical
Products S.A.
Rontis Hellas
Czech Medical And
Products S.A.
Rontis Hellas
Czech Medical And
Products S.A.
2care4
Denmark Lymelysal Lymecycline 300 mg Capsule, hard Oral use
Generics ApS
Accord
Abacavir/ 600 mg/ Film-coated
Denmark Healthcare Abacavir/Lamivudine "Accord" Oral use
B.V.
Aurobindo
Pharma Film-coated
Denmark Leflunomid "Aurobindo" Leflunomide 10 mg Oral use
(Malta) tablet
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 37/248
Member Marketing
form administration
EEA holder
Aurobindo
Pharma Film-coated
Denmark Leflunomid "Aurobindo" Leflunomide 15 mg Oral use
(Malta) tablet
Limited
Emulsion for
Denmark Baxter B.V. Profast Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Denmark Baxter B.V. Profast Propofol 20 mg/ml injection/ Intravenous use
infusion
Brown & Burk
Denmark Lymecyclin "Brown & Burk" Lymecycline 300 mg Capsule, hard Oral use
IR Limited
Denmark Pharmaceutic valsartan/ mg/ 12,5 Oral use
Elpen Amlodipine/
Denmark Pharmaceutic valsartan/ Oral use
Elpen Amlodipine/
Elpen Amlodipine/
Denmark Pharmaceutic valsartan/ mg/ 12,5 Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 38/248
Member Marketing
form administration
EEA holder
Morningside
Denmark Healthcare Dinetrel Amantadine 100 mg Capsule, hard Oral use
(Malta) Ltd
Film-coated
Denmark Mylan AB Erlotinib "Mylan" Erlotinib 25 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Denmark Mylan AB Vildagliptin Mylan Vildagliptin 50 mg Tablet Oral use
Newbury
Film-coated
Denmark Pharmaceutic Lapatinib "Newbury" Lapatinib 250 mg Oral use
tablet
als AB
Orifarm Phenoxymethylpeni Film-coated
Denmark Priminova 800mg Oral use
Generics A/S cillin tablet
Film-coated
Denmark Sandoz A/S Darunavir "Sandoz" Darunavir 600 mg Oral use
tablet
Film-coated
Denmark Sandoz A/S Darunavir "Sandoz" Darunavir 800 mg Oral use
tablet
Film-coated
Denmark Sandoz A/S Erlotinib "Sandoz" Erlotinib 25 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Efavirenz/ 600 mg/
Film-coated
Denmark Sandoz A/S Padviram emtricitabine/ 200 mg/ Oral use
tablet
tenofovir 245 mg
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 39/248
Member Marketing
form administration
EEA holder
Stada
Denmark Arzneimittel Abacavir/Lamivudine "Stada" Oral use
AG
Stada
Denmark Arzneimittel Atazanavir "Stada" Atazanavir 150 mg Capsule, hard Oral use
AG
Stada
AG
Stada
AG
Stada
Film-coated
Denmark Arzneimittel Darunavir Stada Darunavir 400 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada Efavirenz/ 600 mg/
Film-coated
Denmark Arzneimittel Emtenef emtricitabine/ 200 mg/ Oral use
tablet
AG tenofovir 245 mg
Stada
Film-coated
Denmark Arzneimittel Erlotinib "Stada" Erlotinib 25 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 40/248
Member Marketing
form administration
EEA holder
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
Denmark Arzneimittel Lacosamide "Stada" Lacosamide 50 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Denmark Arzneimittel Posaconazole Stada Posaconazole 40 mg/ml Oral suspension Oral use
AG
Stada
Film-coated
Denmark Arzneimittel Tadalafil "Stada Tadalafil 5 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 41/248
Member Marketing
form administration
EEA holder
Stada
Film-coated
tablet
AG
Denmark Teva B.V. Posaconazol "Teva B.V." Posaconazole 40 mg/ ml Oral suspension Oral use
2care4
Denmark Bendatol Albendazole 400 mg Tablet Oral use
Generics ApS
Kappler
Denmark Pharma Betahistin "Kappler" Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
Kappler
Denmark Pharma Betahistin "Kapplerpharma" Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
Pharos
Pharmaceutical
Denmark Nilotinib "PharOS" Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 42/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Film-coated
Denmark Sandoz A/S Sorafenib "Sandoz" Sorafenib 400 mg Oral use
tablet
Viatris
Denmark Healthcare Nilotinib "Viatris" Nilotinib 50 mg Capsule, hard Oral use
Limited
Viatris
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 43/248
Member Marketing
form administration
EEA holder
Viatris
Limited
Accord
Estonia Healthcare Abacavir/Lamivudine Accord Oral use
B.V.
Emulsion for
Estonia Baxter B.V. ANESIA Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Estonia Baxter B.V. ANESIA Propofol 20 mg/ ml injection/ Intravenous use
infusion
LV System
Estonia Service, Suphrex 12.5 mg hard capsules Sunitinib 12,5 mg Capsule, hard Oral use
Latvia
LV System
Estonia Service, Suphrex 50 mg hard capsules Sunitinib 50 mg Capsule, hard Oral use
Latvia
Mylan Ireland
Estonia Posaconazole Mylan Posaconazole 40 mg/ ml Oral suspension Oral use
Limited
Mylan
Film-coated
Estonia Pharmaceutic Erlotinib "Mylan" Erlotinib 100 mg Oral use
tablet
als Limited
Mylan
Film-coated
Estonia Pharmaceutic Erlotinib "Mylan" Erlotinib 150 mg Oral use
tablet
als Limited
Sitagliptin/ Metformin Sitagliptin/ 50 mg/ Film-coated
Estonia Sandoz d.d. Oral use
Hydrochloride Sandoz metformin 850 mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 44/248
Member Marketing
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EEA holder
Sitagliptin/ Metformin Sitagliptin/ 50 mg/ Film-coated

Estonia Sandoz d.d. Oral use
Hydrochloride Sandoz metformin 1000 mg tablet
Sandoz
Film-coated
Estonia Pharmaceutic Darunavir Sandoz Darunavir 75 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
Estonia Pharmaceutic Erlotinib "Sandoz" Erlotinib 100 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
Estonia Pharmaceutic Erlotinib "Sandoz" Erlotinib 150 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
Estonia Pharmaceutic ERLOTINIB SANDOZ Erlotinib 25 mg Oral use
tablet
als d.d.
Sandoz Efavirenz/ 600 mg/
Film-coated
Estonia Pharmaceutic PADVIRAM emtricitabine/ 200 mg/ Oral use
tablet
als d.d. tenofovir 245 mg
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 45/248
Member Marketing
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Sandoz
Film-coated
Estonia Pharmaceutic Sitagliptin Sandoz Sitagliptin 25 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
Estonia Pharmaceutic SORAFENIB SANDOZ Sorafenib 400 mg Oral use
tablet
als d.d.
Vildagliptin/ 50 mg/ Film-coated
Estonia SIA Elvim Vildagliptin/ Metformin Elvim Oral use
Estonia SIA Elvim Vildagliptin/ Metformin Elvim Oral use
Pharos
Pharmaceutical
Estonia NILOTINIB PHAROS Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 46/248
Member Marketing
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EEA holder
Film-coated
Estonia Remedica Ltd. VIAREMBLU Sildenafil 25 mg Oral use
tablet
Film-coated
Estonia Remedica Ltd. Viaremblu Sildenafil 50 mg Oral use
tablet
Film-coated
Estonia Remedica Ltd. Viaremblu Sildenafil 100 mg Oral use
tablet
Sandoz
Prolonged-
Estonia Pharmaceutical Ranzolva Ranolazine 375 mg Oral use
release tablet
s d.d.
Sandoz
Prolonged-
release tablet
s d.d.
Sandoz
Prolonged-
release tablet
s d.d.
Estonia Viatris Limited NILOTINIB VIATRIS Nilotinib 200 mg Capsule, hard Oral use
Estonia Zentiva k.s. NILOTINIB ZENTIVA Nilotinib 150 mg Capsule, hard Oral use
Estonia Zentiva k.s. NILOTINIB ZENTIVA Nilotinib 200 mg Capsule, hard Oral use
Accord
Finland Healthcare Abacavir/Lamivudine Accord Oral use
B.V.
AOP Orphan
Film-coated
Finland Pharmaceutic Tadalafil Aop Tadalafil 20 mg Oral use
tablet
als GmbH
Emulsion for
Finland Baxter B.V. Profast Propofol 10 mg/ml injection/ Intravenous use
infusion
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 47/248
Member Marketing
form administration
EEA holder
Emulsion for
Finland Baxter B.V. Profast Propofol 20 mg/ ml injection/ Intravenous use
infusion
Brown & Burk
Finland Lymecycline Brown & Burk Lymecycline 300 mg Capsule, hard Oral use
IR Limited
Film-coated
Finland Hexal A/S Sitagliptin Hexal Sitagliptin 25 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Sitagliptin/ 50 mg/ Film-coated
Finland Hexal A/S Sitagliptin/Metformin Hexal Oral use
Finland Hexal A/S Sitagliptin/Metformin Hexal Oral use
Amlodipine/Valsartan/Hydrochlo Film-coated
Finland Mylan AB valsartan/ mg/ 12,5 Oral use
rothiazide Mylan tablet
Amlodipine/
Amlodipine/Valsartan/Hydrochlo 5 mg/ 160 Film-coated
Finland Mylan AB valsartan/ Oral use
rothiazide Mylan mg/ 25 mg tablet
hydrochlorothiazide
Finland Mylan AB valsartan/ mg/ 12,5 Oral use
Amlodipine/
hydrochlorothiazide
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 48/248
Member Marketing
form administration
EEA holder
Amlodipine/
hydrochlorothiazide
Finland Mylan AB Vildagliptin Mylan Vildagliptin 50 mg Tablet Oral use
Orion Film-coated
Finland Bosentan Orion Bosentan 62,5 mg Oral use
Corporation tablet
Orion Film-coated
Finland Bosentan Orion Bosentan 125 mg Oral use
Corporation tablet
Orion Orodispersible
Finland Olanzapin Orion Olanzapine Oral use
Corporation 5 mg tablet
Finland Olanzapin Orion Olanzapine 10 mg Oral use
Corporation tablet
Corporation tablet
Corporation tablet
Orion
Finland Olanzapin Orion 10 mg tabletit Olanzapine 10 mg Tablet Oral use
Corporation
Orion
Corporation
Orion
Finland Olanzapin Orion 2.5 mg tabletit Olanzapine 2,5 mg Tablet Oral use
Corporation
Orion
Corporation
Orion
Finland Olanzapin Orion 5 mg tabletit Olanzapine Tablet Oral use
Corporation 5 mg
Orion
Finland Olanzapin Orion 7.5 mg tabletit Olanzapine 7,5 mg Tablet Oral use
Corporation
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 49/248
Member Marketing
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EEA holder
Film-coated
Finland Sandoz A/S Darunavir Sandoz Darunavir 600 mg Oral use
tablet
Film-coated
Finland Sandoz A/S Darunavir Sandoz Darunavir 800 mg Oral use
tablet
Efavirenz/ 600 mg/
Film-coated
Finland Sandoz A/S Padviram emtricitabine/ 200 mg/ Oral use
tablet
tenofovir 245 mg
Stada
Finland Arzneimittel Abacavir/Lamivudine Stada Oral use
AG
Stada
Finland Arzneimittel Atazanavir Stada Atazanavir 200 mg Capsule, hard Oral use
AG
Stada
Finland Arzneimittel Atazanavir Stada Atazanavir 300 mg Capsule, hard Oral use
AG
Stada
Film-coated
Finland Arzneimittel Darunavir Stada Darunavir 600 mg Oral use
tablet
AG
Stada
Film-coated
Finland Arzneimittel Darunavir Stada Darunavir 800 mg Oral use
tablet
AG
Film-coated
Finland Arzneimittel Emtenef emtricitabine/ 200 mg/ Oral use
tablet
AG tenofovir 245 mg
Stada
Film-coated
Finland Arzneimittel Erlotinib Stada Erlotinib 25 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 50/248
Member Marketing
form administration
EEA holder
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
Finland Arzneimittel Lacosamide Stada Lacosamide 50 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Finland Arzneimittel Posaconazole Stada Posaconazole 40 mg/ml Oral suspension Oral use
AG
Stada
Film-coated
Finland Arzneimittel Tadalafil Stada Tadalafil 5 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 51/248
Member Marketing
form administration
EEA holder
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
2care4
Finland Bendatol Albendazole 400 mg Tablet Oral use
Generics ApS
Kappler
Finland Pharma Betahistin Kappler Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
Pharos
Pharmaceutical
Finland Nilotinib Pharos Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 52/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Oriented
Services Ltd.
Metformine Almus 500 mg, Film-coated
France Almus France Metformin 500 mg Oral use
comprimé pelliculé tablet
France Almus France Tramadol Almus 50 mg, gélule Tramadol 50 mg Capsule Oral use
Arrow Atazanavir Arrow 200 mg,
France Atazanavir 200 mg Capsule Oral use
Génériques gélule
Arrow Atazanavir Arrow 300 mg,
France Atazanavir 300 mg Capsule Oral use
Arrow Bosentan Arrow 125 mg, Film-coated
France Bosentan 125 mg Oral use
Génériques comprimé pelliculé tablet
Arrow Bosentan Arrow 62,5 mg, Film-coated
France Bosentan 62,5 mg Oral use
Arrow Digoxine Arrow 0,125 mg,
France Digoxin 0,125 mg Tablet Oral use
Génériques comprimé
Arrow Digoxine Arrow 0,25 mg,
France Digoxin 0,25 mg Tablet Oral use
Génériques comprimé sécable
Arrow Leflunomide Arrow 10 mg, Film-coated
France Leflunomide 10 mg Oral use
Nevirapine Arrow LP 400 mg,
Arrow Prolonged-
France comprimé à libération Nevirapine 400 mg Oral use
Génériques release tablet
prolongée
Olanzapina Arrow 10 mg
Arrow Orodispersible
France comprimé Olanzapine Oral use
Génériques 10 mg tablet
orodispersible
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 53/248
Member Marketing
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EEA holder
France comprimé Olanzapine 15 mg Oral use
Génériques tablet
orodispersible
Génériques tablet
orodispersible
Génériques tablet
orodispersible
Arrow Olanzapine ARROW 10 mg
France Olanzapine 10 mg Tablet Oral use
Arrow Olanzapine ARROW 5 mg
France Olanzapine 5 mg Tablet Oral use
Arrow Olanzapine ARROW 7.5 mg
France Olanzapine 7,5 mg Tablet Oral use
Arrow Racecadotril Arrow 100 mg,
France Racecadotril 100 mg Capsule Oral use
Propofol Baxter 10 mg/ml, Emulsion for
France Baxter B.V. émulsion injectable/pour Propofol 10 mg/ml injection/ Intravenous use
perfusion infusion
Propofol Baxter 20 mg/ml, Emulsion for
France Baxter B.V. émulsion injectable/pour Propofol 20 mg/ ml injection/ Intravenous use
perfusion infusion
Abacavir/Lamivudine Biogaran
France Biogaran 600 mg/300 mg, comprimé Oral use
pelliculé
Atazanavir Biogaran 150 mg,
France Biogaran Atazanavir 150 mg Capsule Oral use
gélule
Annex I
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Member Marketing
form administration
EEA holder

gélule
gélule
Darunavir Biogaran 600 mg, Film-coated
France Biogaran Darunavir 600 mg Oral use
Darunavir Biogaran 800 mg, Film-coated
France Biogaran Darunavir 800 mg Oral use
Efavirenz/Emtricitabine/Tenofov
Efavirenz/ 600 mg/
ir Disoproxil Biogaran 600 Film-coated
France Biogaran emtricitabine/ 200 mg/ Oral use
mg/200 mg/245 mg, comprimé tablet
tenofovir 245 mg
pelliculé
Erlotinib Biogaran 100 mg, Film-coated
France Biogaran Erlotinib 100 mg Oral use
Lapatinib Pharos 250 mg, Film-coated
France Biogaran Lapatinib 250 mg Oral use
Sitagliptine/Metformine BGR 50
France Biogaran mg/1000 mg, comprimé Oral use
pelliculé
EG LABO -
Abacavir/ Lamivudine EG 600 Abacavir/ 600 mg/ Film-coated
France Laboratoires Oral use
mg/300 mg, comprimé pelliculé lamivudine 300 mg tablet
Eurogenerics
Annex I
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Member Marketing
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EEA holder
EG LABO -
Darunavir EG 150 mg, Film-coated
France Laboratoires Darunavir 150 mg Oral use
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Darunavir EG 75 mg, comprimé Film-coated
pelliculé tablet
Eurogenerics
EG LABO -
Eurogenerics
EG LABO - Efavirenz/Emtricitabine/Tenofov Efavirenz/ 600 mg/
Film-coated
France Laboratoires ir Disoproxil EG 600 mg/200 emtricitabine/ 200 mg/ Oral use
tablet
Eurogenerics mg/245 mg, comprimé pelliculé tenofovir 245 mg
EG LABO -
Erlotinib EG 100 mg, comprimé Film-coated
France Laboratoires Erlotinib 100 mg Oral use
pelliculé tablet
Eurogenerics
EG LABO -
pelliculé tablet
Eurogenerics
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 56/248
Member Marketing
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EEA holder
EG LABO -
pelliculé tablet
Eurogenerics
EG LABO -
Lacosamide EG 100 mg, Film-coated
France Laboratoires Lacosamide 100 mg Oral use
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Eurogenerics
EG LABO -
Tadalafil EG 10 mg, comprimé Film-coated
France Laboratoires Tadalafil 10 mg Oral use
pelliculé tablet
Eurogenerics
EG LABO -
Tadalafil EG 2,5 mg, comprimé Film-coated
France Laboratoires Tadalafil 2,5 mg Oral use
pelliculé tablet
Eurogenerics
EG LABO -
pelliculé tablet
Eurogenerics
EG LABO -
pelliculé tablet
Eurogenerics
Annex I
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Member Marketing
form administration
EEA holder
Eugia Pharma
Anastrozole Arrow LAB 1 mg, Film-coated
France (Malta) Anastrozole 1 mg Oral use
Limited
Sitagliptine Evolugen 100 mg, Film-coated
France Evolupharm Sitagliptin 100 mg Oral use
Sitagliptine Evolugen 50 mg, Film-coated
France Evolupharm Sitagliptin 50 mg Oral use
Sitagliptine/Metformine
France Evolupharm Evolugen 50 mg/1000 mg, Oral use
comprimé pelliculé
Laboratoires Kronalis 10 mg, comprimé Film-coated
France Tadalafil 10 mg Oral use
Majorelle pelliculé tablet
Laboratoires Kronalis 2,5 mg, comprimé Film-coated
France Tadalafil 2,5 mg Oral use
Atazanavir Sandoz 200 mg,
France Sandoz Atazanavir 200 mg Capsule Oral use
gélule
France Sandoz Atazanavir 300 mg Capsule Oral use
gélule
Darunavir Sandoz 400 mg, Film-coated
France Sandoz Darunavir 400 mg Oral use
Annex I
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Member Marketing
form administration
EEA holder
Efavirenz/ 600 mg/
ir Disoproxil Sandoz 600 Film-coated
France Sandoz emtricitabine/ 200 mg/ Oral use
mg/200 mg/245 mg, comprimé tablet
tenofovir 245 mg
pelliculé
Erlotinib Sando 100 mg, Film-coated
France Sandoz Erlotinib 100 mg Oral use
Erlotinib Sandoz 150 mg, Film-coated
Sitagliptine GNR 100 mg, Film-coated
France Sandoz Sitagliptin 100 mg Oral use
Sitagliptine GNR 50 mg, Film-coated
France Sandoz Sitagliptin 50 mg Oral use
Sitagliptine/Metformine GNR 50
France Sandoz mg/1000 mg, comprimé Oral use
pelliculé
Deferasirox Teva 900 mg, Film-coated
France Teva Sante Deferasirox 900 mg Oral use
Erlotinib Viatris 100 mg, Film-coated
France Viatris Sante Erlotinib 100 mg Oral use
Posaconazole Viatris 40 mg/mL,
France Viatris Sante Posaconazole 40 mg/ ml Oral suspension Oral use
suspension buvable
Annex I
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Member Marketing
form administration
EEA holder
Vildagliptin Viatris 50 mg, Film-coated

France Viatris Sante Vildagliptin 50 mg Oral use
comprimé tablet
Zentiva Racecadotril Zentiva 100 mg,
France Racecadotril 100 mg Capsule Oral use
France gélule
Arrow Topiramate Arrow 15 mg,
France Topiramate 15 mg Capsule Oral use
Aurobindo Dapaglifozine Metformine Arrow
Dapagliflozin/ 5 mg/ 1000 Film-coated
France Pharma 5 mg/1000 mg, comprimé Oral use
metformin mg tablet
(Malta) Limited pelliculé
Crescent
Pharma Midodrine Hydrochloride 2,5
France Midodrine 2,5 mg Tablet Oral use
International mg, comprimé
Limited
Crescent
Pharma Midodrine Hydrochloride 5 mg,
France Midodrine 5 mg Tablet Oral use
International comprimé
Limited
Generis
Teriflunomide Arrow 14 mg, Film-coated
France Farmacêutica, Teriflunomide 14 mg Oral use
S.A.
Kappler
Betahistine Kappler 24 mg,
France Pharma Betahistine 24 mg Tablet Oral use
comprimé
Consult GmbH
Annex I
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Member Marketing
form administration
EEA holder
Kappler
Betahistine Kappler 8 mg,
France Pharma Betahistine 8 mg Tablet Oral use
comprimé
Consult GmbH
Morningside
France Healthcare Ponade 50 mg, comprimé Dapsone 50 mg Tablet Oral use
(Malta) Ltd.
Nutra Essential Ibuprofene Winadol 400 mg,
France Ibuprofen 400 mg Capsule, soft Oral use
OTC, S.L. capsule molle
Pharos
Pharmaceutical
France Nilotinib Pharos 150 mg, gélules Nilotinib 150 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
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Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
France Nilotinib Pharos200 mg, gélules Nilotinib 200 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
France Nilotinib Viatris 150 mg, gélule Nilotinib 150 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
1 A Pharma Sitagliptin - 1 A Pharma 100 mg Film-coated
Germany Sitagliptin 100 mg Oral use
Sitagliptin/Metformin - 1 A
1 A Pharma Sitagliptin/ 50 mg/ Film-coated
Germany Pharma 50 mg/1000 mg Oral use
GmbH metformin 1000 mg tablet
Filmtabletten
Sitagliptin/Metformin - 1 A
1 A Pharma Sitagliptin/ 50 mg/ Film-coated
Germany Pharma 50 mg/850 mg Oral use
Filmtabletten
Annex I
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Member Marketing
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EEA holder
Aliud Pharma Darunavir AL 400 mg Film-coated

Germany Darunavir 400 mg Oral use
Aliud Pharma Deferasirox AL 900 mg Film-coated
Germany Deferasirox 900 mg Oral use
Aliud Pharma Lapatinib AL 250 mg Film-coated
Germany Lapatinib 250 mg Oral use
Aliud Pharma Posaconazol AL 40 mg/ml
Germany Posaconazole 40 mg/ml Oral suspension Oral use
GmbH Suspension zum Einnehmen
Aliud Pharma Tadalafil AL 10 mg Film-coated
Germany Tadalafil 10 mg Oral use
Aliud Pharma Tadalafil AL 20 mg Film-coated
Aliud Pharma Film-coated
Germany Tadalafil AL 5 mg Filmtabletten Tadalafil 5 mg Oral use
GmbH tablet
Aliud Pharma Tadalafil PAH AL 20 mg Film-coated
Aliud Pharma Abacavir/Lamivudin AL 600 Abacavir/ 600 mg/ Film-coated
Germany Oral use
GmbH mg/300 mg Filmtabletten lamivudine 300 mg tablet
Aliud Pharma Atazanavir AL 150 mg
Germany Atazanavir 150 mg Capsule, hard Oral use
GmbH Hartkapseln
GmbH Hartkapseln
GmbH Hartkapseln
Annex I
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Member Marketing
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EEA holder
Efavirenz/ emtricitabine/ Efavirenz/ 600 mg /

Aliud Pharma Film-coated
Germany tenofovirdis AL 600 mg/200 emtricitabine/ 200 mg / Oral use
GmbH tablet
mg/245 mg Filmtabletten tenofovir 245 mg
Aliud Pharma Lacosamid AL 100 mg Film-coated
Germany Lacosamide 100 mg Oral use
Emulsion for
Propofol Baxter 10 mg/ml
Germany Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Propofol Baxter 10 mg/ml MCT
infusion
Emulsion for
Propofol Baxter 20 mg/ml
Germany Baxter B.V. Propofol 20 mg/ ml injection/ Intravenous use
infusion
Emulsion for
Propofol Baxter 20 mg/ml MCT
infusion
betapharm
Abacavir/Lamivudin beta 600 Abacavir/ 600 mg/ Film-coated
Germany Arzneimittel Oral use
mg/300 mg Filmtabletten lamivudine 300 mg tablet
GmbH
Annex I
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Member Marketing
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EEA holder
betapharm
Atazanavir beta 150 mg
Germany Arzneimittel Atazanavir 150 mg Capsule, hard Oral use
Hartkapseln
GmbH
betapharm
Hartkapseln
GmbH
betapharm
Hartkapseln
GmbH
betapharm Efavirenz/Emtricitabin/Tenofovir Efavirenz/ 600 mg/
Film-coated
Germany Arzneimittel disoproxil beta 600 mg/200 emtricitabine/ 200 mg/ Oral use
tablet
GmbH mg/245 mg Filmtabletten tenofovir 245 mg
betapharm
Posaconazol beta 40 mg/ml
Germany Arzneimittel Posaconazole 40 mg/ ml Oral suspension Oral use
Suspension zum Einnehmen
GmbH
Bluefish
Sutinib Bluefish 12,5 mg
Germany Pharmaceutic Sunitinib 12,5 mg Capsule, hard Oral use
Hartkapseln
als AB
Bluefish
Sutinib Bluefish 25 mg
Germany Pharmaceutic Sunitinib 25 mg Capsule, hard Oral use
Hartkapseln
als AB
Bluefish
Sutinib Bluefish 50 mg
Germany Pharmaceutic Sunitinib 50 mg Capsule, hard Oral use
Hartkapseln
als AB
Brillpharma
Solifenacin Brillpharma 1mg/ml
Germany (Ireland) Solifenacin 1 mg/ml Oral solution Oral use
Lösung zum Einnehmen
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 65/248
Member Marketing
form administration
EEA holder
C4 health Metformin C4 health 1000 mg Film-coated

Germany Metformin 1000 mg Oral use
Denk Pharma
Tadalafil Denk 10 mg Film-coated
Germany GmbH & Co. Tadalafil 10 mg Oral use
KG
Denk Pharma
Tadalafil Denk 2,5 mg Film-coated
Germany GmbH & Co. Tadalafil 2,5 mg Oral use
KG
Denk Pharma
KG
Denk Pharma
KG
Denk Pharma
Vildagliptin Denk 50 mg
Germany GmbH & Co. Vildagliptin 50 mg Tablet Oral use
Tabletten
KG
Elpen Amlodipin/Valsartan/Hydrochlor Amlodipine/ 10 mg/ 160
Film-coated
Germany Pharmaceutic othiazid ELPEN 10 mg/160 valsartan/ mg/ 12,5 Oral use
tablet
al Co. Inc mg/12,5 mg Filmtabletten hydrochlorothiazide mg
Elpen Amlodipin/Valsartan/Hydrochlor Amlodipine/
10 mg/ 160 Film-coated
Germany Pharmaceutic othiazid ELPEN 10 mg/160 valsartan/ Oral use
mg/ 25 mg tablet
al Co. Inc mg/25 mg Filmtabletten hydrochlorothiazide
Annex I
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Member Marketing
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EEA holder

mg/ 25 mg tablet
Elpen Amlodipin/Valsartan/Hydrochlor Amlodipine/ 5 mg/ 160
Film-coated
Germany Pharmaceutic othiazid ELPEN 5 mg/160 valsartan/ mg/ 12,5 Oral use
tablet
al Co. Inc mg/12,5 mg Filmtabletten hydrochlorothiazide mg
mg/ 25 mg tablet
Elpen
Vildagliptin ELPEN 50 mg Film-coated
Germany Pharmaceutic Vildagliptin 50 mg Oral use
Tabletten tablet
al Co. Inc
Eugia Pharma
Anastro Puren 1 mg Film-coated
Germany (Malta) Anastrozole 1 mg Oral use
Limited
Glenmark Posaconazol Glenmark 40
Germany Arzneimittel mg/ml Suspension zum Posaconazole 40 mg Oral suspension Oral use
GmbH Einnehmen
Glenmark
Erlotinib Glenmark 100 mg Film-coated
Germany Arzneimittel Erlotinib 100 mg Oral use
GmbH
Glenmark
GmbH
Glenmark
GmbH
Annex I
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Member Marketing
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EEA holder
Atazanavir HEXAL 200 mg

Germany Hexal AG Atazanavir 200 mg Capsule, hard Oral use
Hartkapseln
Atazanavir HEXAL 300 mg
Germany Hexal AG Atazanavir 300 mg Capsule, hard Oral use
Hartkapseln
Darunavir HEXAL 600 mg Film-coated
Germany Hexal AG Darunavir 600 mg Oral use
Darunavir HEXAL 800 mg Film-coated
Germany Hexal AG Darunavir 800 mg Oral use
Erlotinib Hexal 100 mg Film-coated
Germany Hexal AG Erlotinib 100 mg Oral use
Efavirenz/ 600 mg/
Germany Hexal AG emtricitabine/ 200 mg/ Oral use
mg Filmtabletten tablet
tenofovir 245 mg
Sitagliptin HEXAL 100 mg Film-coated
Germany Hexal AG Sitagliptin 100 mg Oral use
Sitagliptin Metformin HEXAL 50 Sitagliptin/ 50 mg/ Film-coated
Germany Hexal AG Oral use
mg/1000 mg Filmtabletten metformin 1000 mg tablet
Sitagliptin Metformin HEXAL 50 Sitagliptin/ 50 mg/ Film-coated
Germany Hexal AG Oral use
mg/850 mg Filmtabletten metformin 850 mg tablet
Annex I
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Member Marketing
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Sorafenib HEXAL 400 mg Film-coated

Germany Hexal AG Sorafenib 400 mg Oral use
Amlodipin/Valsartan/HCT Amlodipine/ 10 mg/ 160
Holsten Film-coated
Germany Holsten 10 mg/160 mg/12,5 valsartan/ mg/ 12,5 Oral use
Pharma GmbH tablet
Amlodipin/Valsartan/HCT Amlodipine/
Holsten 10 mg/ 160 Film-coated
Germany Holsten 10 mg/160 mg/25 mg valsartan/ Oral use
Pharma GmbH mg/ 25 mg tablet
Filmtabletten hydrochlorothiazide
Holsten Film-coated
Germany Holsten 5 mg/160 mg/12,5 mg valsartan/ mg/ 12,5 Oral use
Pharma GmbH tablet
Filmtabletten hydrochlorothiazide mg
Klinge Pharma
Germany Diaverde 100 mg Hartkapseln Racecadotril 100 mg Capsule, hard Oral use
GmbH
Pilocarpinhydrochlorid Milstein 5 Film-coated
Germany Milstein C.V. Pilocarpine 5 mg Oral use
mg Filmtabletten tablet
Pharmaselect
International
Germany Colchanova 0,5 mg Tabletten Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Annex I
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Member Marketing
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EEA holder
Pharmaselect
International
Germany Colchanova 1 mg Tabletten Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
PUREN
Olanzapin Aurobindo 10 mg
Germany Pharma GmbH Olanzapine 10 mg Tablet Oral use
Tabletten
& Co. KG
PUREN
Tabletten
& Co. KG
PUREN
Olanzapin Aurobindo 2.5 mg
Germany Pharma GmbH Olanzapine 2,5 mg Tablet Oral use
Tabletten
& Co. KG
PUREN
Tabletten
& Co. KG
PUREN
Germany Pharma GmbH Olanzapine Tablet Oral use
Tabletten 5 mg
& Co. KG
PUREN
Olanzapin Aurobindo 7.5 mg
Germany Pharma GmbH Olanzapine 7,5 mg Tablet Oral use
Tabletten
& Co. KG
Puren Pharma
Bosentan Puren 125 mg Film-coated
Germany GmbH & Co. Bosentan 125 mg Oral use
KG
Puren Pharma
Bosentan Puren 62,5 mg Film-coated
Germany GmbH & Co. Bosentan 62,5 mg Oral use
KG
Annex I
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Member Marketing
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Puren Pharma
Leflunomid Puren 10 mg Film-coated
Germany GmbH & Co. Leflunomide 10 mg Oral use
KG
Puren Pharma
Leflunomid Puren 15 mg Film-coated
Germany GmbH & Co. Leflunomide 15 mg Oral use
KG
Puren Pharma
Nevirapin Aurobindo 400 mg Prolonged-
Germany GmbH & Co. Nevirapine 400 mg Oral use
Retardtabletten release tablet
KG
ratiopharm Deferasirox-ratiopharm 900 mg Film-coated
Posaconazol-ratiopharm 40
ratiopharm
Germany mg/ml Suspension zum Posaconazole 40 mg/ ml Oral suspension Oral use
GmbH
Einnehmen
Stadapharm Deferasirox Stada 900 mg Film-coated
Stadapharm Erlotinib Stada 100 mg Film-coated
Germany Erlotinib 100 mg Oral use
Stadapharm Lacosamid Stada 100 mg Film-coated
Annex I
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Member Marketing
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Stadapharm Lapatinib Stada 250 mg Film-coated
Germany Lapatinib 250 mg Oral use
Stadapharm Sorafenib Stada 400 mg Film-coated
Germany Sorafenib 400 mg Oral use
Stadapharm Tadalafil Stada 10 mg Film-coated
Umedica
Atorvastatin Umedica 10 mg Film-coated
Germany Netherlands Atorvastatin 10 mg Oral use
B.V.
Umedica
B.V.
Umedica
B.V.
Umedica
B.V.
Annex I
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Member Marketing
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Umedica
Carbamazepin Umedica 100 mg
Germany Netherlands Carbamazepine 100 mg Tablet Oral use
Tabletten
B.V.
Umedica
Tabletten
B.V.
Umedica
Tabletten
B.V.
Umedica
Deferasirox Umedica 180 mg Film-coated
Germany Netherlands Deferasirox 180 mg Oral use
B.V.
Umedica
B.V.
Umedica
B.V.
Umedica
Pirfenidon Umedica 267 mg Film-coated
Germany Netherlands Pirfenidone 267 mg Oral use
B.V.
Umedica
Pirfenidon Umedica 801 mg Film-coated
Germany Netherlands Pirfenidone 801 mg Oral use
B.V.
Umedica
Ranolazin Umedica 375 mg Prolonged-
Germany Netherlands Ranolazine 375 mg Oral use
B.V.
Annex I
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Member Marketing
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Umedica
B.V.
Umedica
B.V.
Umedica
Sildenafil Umedica 20 mg Film-coated
Germany Netherlands Sildenafil 20 mg Oral use
B.V.
Film-coated
Germany Zentiva k.s. Zentiva 10 mg/160 mg/12,5 valsartan/ mg/ 12,5 Oral use
tablet
Germany Zentiva k.s. Zentiva 10 mg/160 mg/25 mg valsartan/ Oral use
mg/ 25 mg tablet
mg/ 25 mg tablet
Film-coated
Germany Zentiva k.s. Zentiva 5 mg/160 mg/12,5 mg valsartan/ mg/ 12,5 Oral use
tablet
Filmtabletten hydrochlorothiazide mg
mg/ 25 mg tablet
Zentiva Posaconazol Zentiva 40 mg/ml
Germany Posaconazole 40 mg/ ml Oral suspension Oral use
Pharma GmbH Suspension zum Einnehmen
2care4
Germany Bendatol Albendazole 400 mg Tablet Oral use
Generics ApS
Annex I
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Member Marketing
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EEA holder
Aurobindo Dapagliflozin/ Metformin

Germany Pharma Aurobindo 5 mg/ 1000 mg Oral use
metformin mg tablet
(Malta) Limited Filmtabletten
Aurobindo Dapagliflozin/ Metformin
Germany Pharma Aurobindo 5 mg/ 850 mg Oral use
metformin mg tablet
(Malta) Limited Filmtabletten
Aurobindo
Dapagliflozin/Metformin PUREN Dapagliflozin/ 5 mg/ 1000 Film-coated
Germany Pharma Oral use
5 mg 100 mg Filmtabletten metformin mg tablet
(Malta) Limited
Aurobindo
Dapagliflozin/Metformin PUREN Dapagliflozin/ 5 mg/ 850 Film-coated
Germany Pharma Oral use
5 mg 850 mg Filmtabletten metformin mg tablet
(Malta) Limited
Germany Devatis GmbH Eltrombopag 12,5 mg Oral use
Germany Devatis GmbH Eltrombopag 25 mg Oral use
Elpen
Prolonged-
Germany Pharmaceutical Ralaxa 375 mg Retardtabletten Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 75/248
Member Marketing
form administration
EEA holder
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Ranange 375 mg Prolonged-
Germany Pharmaceutical Ranolazine 375 mg Oral use
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Ranolazin beta 375 mg Prolonged-
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Ranolazin Heumann 375 mg Prolonged-
Co. Inc.
Elpen
Co. Inc.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 76/248
Member Marketing
form administration
EEA holder
Elpen
Co. Inc.
Elpen
Ranolazine ELPEN 375 mg Prolonged-
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Ranolpen 375 mg Prolonged-
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Raupresil 375 mg Prolonged-
Co. Inc.
Elpen
Co. Inc.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 77/248
Member Marketing
form administration
EEA holder
Elpen
Co. Inc.
Elpen
Prolonged-
Germany Pharmaceutical Rovalo 375 mg Retardtabletten Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Generis
Teriflunomid PUREN 14 mg Film-coated
Germany Farmacêutica, Teriflunomide 14 mg Oral use
S.A.
Generis
Trazodon PUREN 100 mg Film-coated
Germany Farmacêutica, Trazodone 100 mg Oral use
S.A.
Generis Phar, Teriflunomid Aurobindo 14 mg Film-coated
Germany Teriflunomide 14 mg Oral use
Unipessoal Lda Filmtabletten tablet
Hexal
RanolaHexal 375 mg Prolonged-
Germany Aktiengesellsch Ranolazine 375 mg Oral use
aft
Hexal
aft
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 78/248
Member Marketing
form administration
EEA holder
Hexal
aft
Hexal
Ranzolva 375 mg Prolonged-
aft
Hexal
aft
Hexal
aft
Ranolazin - 1 A Pharma 375 mg Prolonged-
Germany Hexal AG Ranolazine 375 mg Oral use
Kappler
Betahistin Kappler 16 mg
Germany Pharma Betahistine 16 mg Tablet Oral use
Tabletten
Consult GmbH
Kappler
Tabletten
Consult GmbH
Kappler
Tabletten
Consult GmbH
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 79/248
Member Marketing
form administration
EEA holder
Kappler
Betahistin Kapplerpharma 16
mg Tabletten
Consult GmbH
Kappler
Betahistin Kapplerpharma 24
mg Tabletten
Consult GmbH
Kappler
Betahistin Kapplerpharma 8 mg
Tabletten
Consult GmbH
Morningside
Mercaptopurine Morningside 10
Germany Healthcare Mercaptopurine 10 mg Tablet Oral use
mg Tabletten
(Malta) Ltd.
Morningside
Mercaptopurine Morningside 50
Germany Healthcare Mercaptopurine 50 mg Tablet Oral use
mg Tabletten
(Malta) Ltd.
Trazodon neuraxpharm 150 mg
Neuraxpharm Modified-release
Germany Tabletten mit veränderter Trazodone 150 mg Oral use
Bohemia s.r.o. tablet
Wirkstofffreisetzung
Trazodon neuraxpharm 75 mg
Neuraxpharm Modified-release
Germany Tabletten mit veränderter Trazodone 75 mg Oral use
Bohemia s.r.o. tablet
Wirkstofffreisetzung
Phagecon -
Servicos e Trazodon Phagecon 150 mg
Modified-release
Germany Consultoria Tabletten mit veränderter Trazodone 150 mg Oral use
tablet
Farmaceutica, Wirkstofffreisetzung
Lda.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 80/248
Member Marketing
form administration
EEA holder
Phagecon -
Modified-release
Germany Consultoria Tabletten mit veränderter Trazodone 75 mg Oral use
tablet
Lda.
PharmConsul Olanzapine Oro PharmConsul Orodispersible
Germany Olanzapine 10 mg Oral use
s.r.o. 10 mg Schmelztabletten tablet
PharmConsul Olanzapine Oro PharmConsul 5 Orodispersible
s.r.o. mg Schmelztabletten tablet
Pharos
Germany Nilotinib 150 mg Capsule, hard Oral use
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 81/248
Member Marketing
form administration
EEA holder
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Pharmaceutical
Germany Nilotinib Viatris Hartkapseln Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
Torrent
Film-coated
Germany Pharma Pazopanib 200 mg Pazopanib 200 mg Oral use
tablet
(Malta) Ltd
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 82/248
Member Marketing
form administration
EEA holder
Umedica Dimethyl Fumarat Umedica 120

Gastro-resistant
Germany Netherlands mg magensaftresistente Dimethyl fumarate 120 mg Oral use
capsule, hard
B.V. Hartkapseln
Umedica Dimethyl Fumarat Umedica 240
Gastro-resistant
Germany Netherlands mg magensaftresistente Dimethyl fumarate 240 mg Oral use
capsule, hard
B.V. Hartkapseln
Umedica
Oxcarbazepin 150 mg Film-coated
Germany Netherlands Oxcarbazepine 150 mg Oral use
B.V.
Umedica
B.V.
Umedica
B.V.
Prolonged-
Germany Zentiva k.s. Zymela 375 mg Retardtabletten Ranolazine 375 mg Oral use
release tablet
Prolonged-
release tablet
Prolonged-
release tablet
Emulsion for
Greece Baxter B.V. Propofol Baxter Propofol 10 mg/ml injection/ Intravenous use
infusion
Elpen
Film-coated
Greece Pharmaceutic Antorcin Atorvastatin 10 mg Oral use
tablet
al Co. Inc
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 83/248
Member Marketing
form administration
EEA holder
Elpen
Film-coated
Greece Pharmaceutic Dodefar Darunavir 75 mg Oral use
tablet
al Co. Inc
Elpen
Film-coated
Greece Pharmaceutic Dodefar Darunavir Oral use
150 mg tablet
al Co. Inc
Elpen
Film-coated
tablet
al Co. Inc
Elpen
Film-coated
tablet
al Co. Inc
Elpen
Film-coated
tablet
al Co. Inc
Elpen
Film-coated
tablet
al Co. Inc
Elpen
Amlodipine/ 5 mg/ 150 Film-coated
Greece Pharmaceutic Ebimia Oral use
irbesartan mg tablet
al Co. Inc
Elpen
al Co. Inc
Elpen
al Co. Inc
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 84/248
Member Marketing
form administration
EEA holder
Elpen
al Co. Inc
Elpen Efavirenz/ 600 mg/
Film-coated
Greece Pharmaceutic Hemocinol emtricitabine/ 200 mg/ Oral use
tablet
al Co. Inc tenofovir 245 mg
Elpen
Film-coated
Greece Pharmaceutic Issoferrol Max Deferasirox 900 mg Oral use
tablet
al Co. Inc
Elpen
Greece Pharmaceutic Padlas Vildagliptin 50 mg Tablet Oral use
al Co. Inc
Film-coated
Greece Pharmaceutic Valsimia HCT valsartan/ mg/ 12,5 Oral use
tablet
Elpen Amlodipine/
Greece Pharmaceutic Valsimia HCT valsartan/ Oral use
mg/ 25 mg tablet
Film-coated
Greece Pharmaceutic Valsimia HCT valsartan/ mg/ 12,5 Oral use
tablet
Elpen Amlodipine/
mg/ 25 mg tablet
Elpen Amlodipine/
mg/ 25 mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 85/248
Member Marketing
form administration
EEA holder

Amlodipine+Valsartan+Hydroch Film-coated
Greece Enorasis valsartan/ mg/ 12,5 Oral use
lorothiazide/ Aenorasis tablet
Amlodipine/
Amlodipine+Valsartan+Hydroch 10 mg/ 160 Film-coated
Greece Enorasis valsartan/ Oral use
lorothiazide/ Aenorasis mg/ 25 mg tablet
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Amlodipine+Valsartan+Hydroch Film-coated
Greece Enorasis valsartan/ mg/ 12,5 Oral use
lorothiazide/ Aenorasis tablet
Genepharm
Greece Posaconazole Genepharm Posaconazole 40 mg/ ml Oral suspension Oral use
S.A.
Genepharm Amlodipine+Valsartan+Hydroch Film-coated
Greece valsartan/ mg/ 12,5 Oral use
S.A. lorothiazide/ Genepharm tablet
Amlodipine/
Genepharm Amlodipine+Valsartan+Hydroch 5 mg/ 160 Film-coated
Greece valsartan/ Oral use
S.A. lorothiazide/ Genepharm mg/ 25 mg tablet
hydrochlorothiazide
Genepharm Amlodipine+Valsartan+Hydroch Film-coated
Greece valsartan/ mg/ 12,5 Oral use
S.A. lorothiazide/ Genepharm tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 86/248
Member Marketing
form administration
EEA holder
Amlodipine/
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Genepharm
Greece Egotux Sunitinib 50 mg Capsule, hard Oral use
S.A.
Genepharm
Greece Egotux Sunitinib 12,5 mg Capsule, hard Oral use
S.A.
Genepharm
Greece Egotux Sunitinib 25 mg Capsule, hard Oral use
S.A.
Genepharm
Greece Egotux Sunitinib 37,5 mg Capsule, hard Oral use
S.A.
Genepharm Film-coated
Greece Genement Tadalafil 2,5 mg Oral use
S.A. tablet
Greece Genement Tadalafil 5 mg Oral use
S.A. tablet
S.A. tablet
S.A. tablet
Greece Lacosamide Genepharm Lacosamide 50 mg Oral use
S.A. tablet
S.A. tablet
S.A. tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 87/248
Member Marketing
form administration
EEA holder
S.A. tablet
Genepharm Vildagliptin/ 50 mg/ Film-coated
Greece Radicut Oral use
S.A. metformin 850 mg tablet
Genepharm Vildagliptin/ 50 mg/ Film-coated
Greece Radicut Oral use
S.A. metformin 1000 mg tablet
Genepharm
Greece Vildagliptin Genepharm Vildagliptin 50 mg Tablet Oral use
S.A.
Mylan Ireland Film-coated
Greece Erlotinib Mylan Erlotinib 100 mg Oral use
Limited tablet
Greece Erlotinib Mylan Erlotinib 150 mg Oral use
Limited tablet
Pharmaselect
International
Greece Colchicin/Pharmaselect Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Pharmaselect
International
Greece Colchicin/Pharmaselect Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Prolonged-
Greece Rafarm Ranolazine Rafarm Ranolazine 375 mg Oral use
release tablet
Prolonged-
release tablet
Prolonged-
release tablet
Greece Sandoz d.d. Sitagliptin+ Metformin Sandoz Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 88/248
Member Marketing
form administration
EEA holder

Greece Sandoz d.d. Sitagliptin+ Metformin Sandoz Oral use
Film-coated
Greece Sandoz d.d. Sorafenib Sandoz Sorafenib 400 mg Oral use
tablet
Sandoz
Film-coated
Greece Pharmaceutic Sitagliptin Sandoz 100 mg Sitagliptin 100 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Sandoz
Film-coated
tablet
als d.d.
Greece Viatris Limited Tuttecvi Vildagliptin 50 mg Tablet Oral use
Win Medica Amlodipine/ 5 mg/ 150 Film-coated
Greece Combipress Oral use
S.A. irbesartan mg tablet
Win Medica Film-coated
Greece Combipress Plus irbesartan / mg/ 12,5 Oral use
S.A. tablet
Win Medica Film-coated
Greece Combipress Plus irbesartan / mg/ 12,5 Oral use
S.A. tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 89/248
Member Marketing
form administration
EEA holder
Win Medica Prolonged-

Greece Retaform Metformin 500 mg Oral use
S.A. release tablet
S.A. release tablet
S.A. release tablet
Win Medica
Greece Vildus Vildagliptin 50 mg Tablet Oral use
S.A.
Elpen
Prolonged-
Greece Pharmaceutical Roxaza Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
Greece Pharmaceutical Zirana/Jexera Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Greece Bottiar Linagliptin 5 mg Oral use
S.A. tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 90/248
Member Marketing
form administration
EEA holder
Greece LAFAVAL Tadalafil 20 mg Oral use
S.A. tablet
Prolonged-
Greece Innovis Renofrin Ranolazine 375 mg Oral use
release tablet
Prolonged-
release tablet
Prolonged-
release tablet
Pharos
Pharmaceutical
Greece Nilotinib Pharos Nilotinib 200 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Greece Nilotinib Pharos Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Greece NILOTINIB PHAROS Nilotinib 150 mg Capsule Oral use
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 91/248
Member Marketing
form administration
EEA holder
Sandoz
Prolonged-
Greece Pharmaceutical RANOLAZINE/SANDOZ Ranolazine 375 mg Oral use
release tablet
s d.d.
Sandoz
Prolonged-
release tablet
s d.d.
Sandoz
Prolonged-
release tablet
s d.d.
Greece Viatris Limited Nilotinib Viatris Nilotinib 200 mg Capsule, hard Oral use
Greece Viatris Limited Nilotinib Viatris Nilotinib 150 mg Capsule, hard Oral use
Greece Ranange Ranolazine 375 mg Oral use
S.A. release tablet
S.A. release tablet
S.A. release tablet
1 A Pharma SITAGLIPTIN 1 A PHARMA 100 Film-coated
Hungary Sitagliptin 100 mg Oral use
GmbH mg filmtabletta tablet
SITAGLIPTIN/METFORMIN 1 A
1 A Pharma Sitagliptin/ 50 mg / Film-coated
Hungary PHARMA 50 mg/1000 mg Oral use
filmtabletta
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 92/248
Member Marketing
form administration
EEA holder
SITAGLIPTIN/METFORMIN 1 A
1 A Pharma Sitagliptin/ 50 mg / Film-coated
Hungary PHARMA 50 mg/850 mg Oral use
filmtabletta
Hungary Losmorid 50 mg filmtabletta Lacosamide 50 mg Oral use
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
AOP Orphan
TADALAFIL AOP 20 mg Film-coated
Hungary Pharmaceutic Tadalafil 20 mg Oral use
filmtabletta tablet
als GmbH
Elpen
Hungary Pharmaceutic Padlas 50 mg Tabletta Vildagliptin 50 mg Tablet Oral use
al Co. Inc
Elpen
Vildagliptin Elpen 50 mg
Hungary Pharmaceutic Vildagliptin 50 mg Tablet Oral use
tabletta
al Co. Inc
Genepharm Lacosamide/Genepharm 100 Film-coated
Hungary Lacosamide 100 mg Oral use
S.A. mg filmtabletta tablet
Genepharm Lacosamide/Genepharm 50 mg Film-coated
S.A. filmtabletta tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 93/248
Member Marketing
form administration
EEA holder
Genepharm Posaconazole Genepharm 40

Hungary Posaconazole 40 mg/ ml Oral suspension Oral use
S.A. mg/ml szuszpenzió
Genepharm Radicut 50 mg/1000 mg Vildagliptin/ 50 mg/ Film-coated
Hungary Oral use
S.A. filmtabletta metformin 1000 mg tablet
Genepharm Radicut 50 mg/850 mg Vildagliptin/ 50 mg/ Film-coated
Hungary Oral use
S.A. filmtabletta metformin 850 mg tablet
Pharmascienc
e Erlotinib Pharmascience 100 mg Film-coated
Hungary Erlotinib 100 mg Oral use
International filmtabletta tablet
Limited
Pharmascienc
e Erlotinib Pharmascience 150 mg Film-coated
International filmtabletta tablet
Limited
Pharmevid
Hungary Sunitinib Pharmevid Sunitinib 12.5 mg Capsule, hard Oral use
s.r.o.
Pharmevid
Hungary Sunitinib Pharmevid Sunitinib 25 mg Capsule, hard Oral use
s.r.o.
Pharmevid
Hungary Sunitinib Pharmevid Sunitinib 50 mg Capsule, hard Oral use
s.r.o.
Sandoz
Hungária Erlotinib Sandoz 100 mg, Film-coated
Kereskedelmi filmtabletta tablet
Kft.
Sandoz
Kft.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 94/248
Member Marketing
form administration
EEA holder
Sandoz
Kft.
Sandoz
Kft.
Sandoz
Kft.
Sandoz
Kft.
Stada
Erlotinib Stada 100 mg Film-coated
Hungary Arzneimittel Erlotinib 100 mg Oral use
filmtabletta tablet
AG
Stada
filmtabletta tablet
AG
Stada
filmtabletta tablet
AG
Stada
filmtabletta tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 95/248
Member Marketing
form administration
EEA holder
Stada
SORAFENIB STADA 400 mg Film-coated
Hungary Arzneimittel Sorafenib 400 mg Oral use
filmtabletta tablet
AG
Vildagliptin/metformin
Hungary Supremex Kft. Supremex 50/1000 mg Oral use
filmtabletta
Erlotinib Mylan 100 mg Film-coated
Hungary Viatris Limited Erlotinib 100 mg Oral use
filmtabletta tablet
filmtabletta tablet
filmtabletta tablet
filmtabletta tablet
Hungary Vipharm S.A. Anvildis 50 mg tabletta Vildagliptin 50 mg Tablet Oral use
Anvildismet 50 mg/1000 mg Vildagliptin/ 50 mg/ Film-coated
Hungary Vipharm S.A. Oral use
filmtabletta metformin 1000 mg tablet
Anvildismet 50 mg/850 mg Vildagliptin/ 50 mg/ Film-coated
Hungary Vipharm S.A. Oral use
filmtabletta metformin 850 mg tablet
Win Medica
Hungary Vildus 50 mg Tabletta Vildagliptin 50 mg Tablet Oral use
S.A.
Film-coated
Hungary Zentiva k.s. Varlota 100 mg filmtabletta Erlotinib 100 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 96/248
Member Marketing
form administration
EEA holder
NilotinibAenorasis 150 mg
Hungary Aenorasis S.A. Nilotinib 150 mg Capsule, hard Oral use
kemény kapszula
kemény kapszula
kemény kapszula
Egis
Hungary Pharmaceutical Granoza 150 mg hard capsules Nilotinib 150 mg Capsule, hard Oral use
s PLC
Egis
s PLC
Egis
s PLC
Kappler
Hungary Pharma Betahistine 16 mg Tablet Oral use
tabletta
Consult GmbH
Kappler
tabletta
Consult GmbH
Kappler
tabletta
Consult GmbH
Pharmascience
Nilotinib Pharmascience 150 mg
Hungary International Nilotinib 150 mg Capsule, hard Oral use
kemény kapszula
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 97/248
Member Marketing
form administration
EEA holder
Pharmascience
Nilotinib Pharmascience 200 mg
Hungary International Nilotinib 200 mg Capsule, hard Oral use
kemény kapszula
Limited
Pharos
Pharmaceutical Evaness 150 mg mg kemény
Hungary Nilotinib 150 mg Capsule, hard Oral use
Oriented kapszula
Services Ltd.
Pharos
Pharmaceutical Evaness 200 mg kemény
Oriented kapszula
Services Ltd.
Pharos
Pharmaceutical Evaness 50 mg mg kemény
Oriented kapszula
Services Ltd.
Pharos
Pharmaceutical Nilotinib Pharos 200mg hard
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 98/248
Member Marketing
form administration
EEA holder
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Nilotinib Viatris 150 mg kemény
Hungary Viatris Limited Nilotinib 150 mg Capsule, hard Oral use
kapszula
kapszula
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 99/248
Member Marketing
form administration
EEA holder

kapszula
Nilotinib Zentiva 150 mg
Hungary Zentiva k.s. Nilotinib 150 mg Capsule, hard Oral use
kemény kapszula
Nilotinib Zentiva 200mg
kemény kapszula
Nilotinib Zentiva 50 mg kemény
kapszula
Newbury
Film-coated
Iceland Pharmaceutic Lapatinib Newbury Lapatinib 250 mg Oral use
tablet
als AB
Efavirenz/ 600 mg/
Film-coated
Iceland Sandoz A/S Padviram emtricitabine/ 200 mg/ Oral use
tablet
tenofovir 245 mg
Stada
Iceland Arzneimittel Atazanavir Stada Atazanavir 150 mg Capsule, hard Oral use
AG
Stada
AG
Stada
AG
Stada
Film-coated
Iceland Arzneimittel Lacosamide Stada Lacosamide 100 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 100/248
Member Marketing
form administration
EEA holder
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Kappler
Iceland Pharma Betahistin Kappler Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
Pharos
Pharmaceutical
Iceland Nilotinib PharOS Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 101/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Iceland Nilotinib Viatris Nilotinib 50 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Emulsion for
Propofol 10 mg/ml Emulsion for
Ireland Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
injection/infusion
infusion
Emulsion for
Propofol 20 mg/ml Emulsion for
Ireland Baxter B.V. Propofol 20 mg/ml injection/ Intravenous use
injection/infusion
infusion
Bluefish
Pharmaceutic
Ireland Sunitinib Bluefish Sunitinib 12,5 mg Capsule, hard Oral use
als AB
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 102/248
Member Marketing
form administration
EEA holder
Bluefish
Pharmaceutic
Ireland Sunitinib Bluefish Sunitinib 25 mg Capsule, hard Oral use
als AB
Bluefish
Pharmaceutic
Ireland Sunitinib Bluefish Sunitinib 50 mg Capsule, hard Oral use
als AB
Brillpharma
Ireland (Ireland) Trazodone hydrochloride Trazodone 50 mg Capsule, hard Oral use
Limited
Brillpharma
Ireland (Ireland) Trazodone hydrochloride Trazodone 100 mg Capsule, hard Oral use
Limited
Brillpharma
Film-coated
Ireland (Ireland) Trazodone hydrochloride Trazodone 150 mg Oral use
tablet
Limited
Brown & Burk Film-coated
Ireland Nefopam hydrochloride Nefopam 30 mg Oral use
IR Limited tablet
Brown & Burk
Ireland Rimicorim Lymecycline 300 mg Capsule, hard Oral use
IR Limited
Clonmel Darunavir Clonmel 600 mg film- Film-coated
Ireland Darunavir 600 mg Oral use
Healthcare Ltd coated tablets tablet
Clonmel Darunavir Clonmel 800 mg film- Film-coated
Ireland Darunavir 800 mg Oral use
Healthcare Ltd coated tablets tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 103/248
Member Marketing
form administration
EEA holder
Efavirenz/ 600 mg/
Clonmel ir Disoproxil Clonmel 600 Film-coated
Ireland emtricitabine/ 200 mg/ Oral use
Healthcare Ltd mg/200 mg/245 mg film-coated tablet
tenofovir 245 mg
tablets
Crescent
Pharma Gastro-resistant
Ireland Dilacort Prednisolone 2,5 mg Oral use
International tablet
Limited
Crescent
Pharma Gastro-resistant
Ireland Dilacort Prednisolone 5 mg Oral use
International tablet
Limited
Ireland Milstein C.V. Midodrine hydrochloride tablets Midodrine 2,5 mg Tablet Oral use
Ireland Milstein C.V. Midodrine hydrochloride tablets Midodrine 5 mg Tablet Oral use
Pharmafile Film-coated
Ireland Nortriptyline Nortriptyline 10 mg Oral use
Limited tablet
Pharmafile Film-coated
Ireland Nortriptyline Nortriptyline 25 mg Oral use
Limited tablet
Atazanavir Rowex 300 mg
Ireland Rowex Ltd. Atazanavir 300 mg Capsule, hard Oral use
Capsules hard
Darunavir Rowex 800 mg Film- Film-coated
Ireland Rowex Ltd. Darunavir 800 mg Oral use
coated tablets tablet
Syri Pharma
Limited t/a
Ireland Dipyridamole Dipyridamole 40 mg/ ml Oral suspension Oral use
Thame
Laboratories
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 104/248
Member Marketing
form administration
EEA holder
Syri Pharma
Limited t/a 2,5 mg/ 5
Ireland Oxybutynin hydrochloride Oxybutynin Oral solution Oral use
Thame ml
Laboratories
Syri Pharma
Limited t/a
Ireland Oxybutynin hydrochloride Oxybutynin 5 mg/ 5 ml Oral solution Oral use
Thame
Laboratories
Pharos
Ireland Nilotinib 150 mg Capsule, hard Oral use
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Film-coated
Italy Almus S.R.L. Metformina Almus Metformin 500 mg Oral use
tablet
Aurobindo
Amiloride E Idroclorotiazide Amiloride/ 5 mg/ 50
Italy Pharma Tablet Oral use
Aurobindo hydrochlorothiazide mg
(Italia) S.r.L.
Aurobindo
Film-coated
Italy Pharma Bosentan Aurobindo Bosentan 62,5 mg Oral use
tablet
(Italia) S.r.L.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 105/248
Member Marketing
form administration
EEA holder
Aurobindo
Film-coated
Italy Pharma Bosentan Aurobindo Bosentan 125 mg Oral use
tablet
(Italia) S.r.L.
Aurobindo
Italy Pharma Olanzapina Aurobindo Olanzapine 10 mg Tablet Oral use
(Italia) S.r.L.
Aurobindo
Italy Pharma Olanzapina Aurobindo Olanzapine 2,5 mg Tablet Oral use
(Italia) S.r.L.
Aurobindo
Italy Pharma Olanzapina Aurobindo Olanzapine Tablet Oral use
5 mg
(Italia) S.r.L.
Aurobindo
Italy Pharma Olanzapina Aurobindo Olanzapine 7,5 mg Tablet Oral use
(Italia) S.r.L.
Aurobindo
Olanzapina Aurobindo Pharma Orodispersible
Italy Pharma Olanzapine Oral use
Italia 10 mg tablet
(Italia) S.r.L.
Aurobindo
Italy Pharma Olanzapine 15 mg Oral use
Italia tablet
(Italia) S.r.L.
Aurobindo
Italia tablet
(Italia) S.r.L.
Aurobindo
Italia tablet
(Italia) S.r.L.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 106/248
Member Marketing
form administration
EEA holder
Emulsion for
Baxter
Italy Rapiva Propofol 10 mg/ml injection/ Intravenous use
Holding B.V.
infusion
Emulsion for
Baxter
Italy Rapiva Propofol 20 mg/ml injection/ Intravenous use
Holding B.V.
infusion
DOC Generici Film-coated
Italy Sitagliptin DOC Generici Sitagliptin 100 mg Oral use
S.r.l. tablet
S.r.l. tablet
S.r.l. tablet
DOC Generici Sitagliptin e metformina DOC Sitagliptin/ 50 mg/ Film-coated
Italy Oral use
S.r.l. Generici metformin 1000 mg tablet
DOC Generici Sitagliptin e metformina DOC Sitagliptin/ 50 mg/ Film-coated
Italy Oral use
S.r.l. Generici metformin 850 mg tablet
Dr. Reddy's Abacavir e Lamivudina Dr. Abacavir/ 600 Film-coated
Italy Oral use
S.r.l. Reddy's lamivudine mg/300 mg tablet
Film-coated
Italy EG SpA Lacosamide EG Lacosamide 150 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Film-coated
tablet
Film-coated
Italy EG SpA Lapatinib EG Lapatinib 250 mg Oral use
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 107/248
Member Marketing
form administration
EEA holder
Italy EG SpA Posaconazolo EG Posaconazole 40 mg/ml Oral suspension Oral use

Film-coated
Italy EG SpA Tadalafil EG Tadalafil 5 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Eugia Pharma
Film-coated
Italy (Malta) Anastrozolo Aurobindo Italia Anastrozole 1 mg Oral use
tablet
Limited
Amlodipinea/Valsartan/ Film-coated
Italy Mylan SpA valsartan/ mg/ 12,5 Oral use
Idroclorotiazide Mylan Pharma tablet
Amlodipine/
Amlodipinea/Valsartan/ 5 mg/ 160 Film-coated
Italy Mylan SpA valsartan/ Oral use
Idroclorotiazide Mylan Pharma mg/ 25 mg tablet
hydrochlorothiazide
Amlodipinea/Valsartan/ Film-coated
Italy Mylan SpA valsartan/ mg/ 12,5 Oral use
Idroclorotiazide Mylan Pharma tablet
Amlodipine/
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Film-coated
Italy Mylan SpA Erlotinib Mylan Erlotinib 100 mg Oral use
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 108/248
Member Marketing
form administration
EEA holder
Film-coated
Italy Mylan SpA Erlotinib Mylan Erlotinib 150 mg Oral use
tablet
Italy Mylan SpA Posaconazolol Mylan Posaconazole 40 mg/ ml Oral suspension Oral use
Italy Mylan SpA Vildagliptin Mylan Vildagliptin 50 mg Tablet Oral use
Pharmaselect
International
Italy Colcamexx Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Pharmaselect
International
Italy Colchicina Pharmaselect Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Sitagliptin e Metformina Sandoz Sitagliptin/ 50 mg/ Film-coated
Italy Sandoz GmbH Oral use
Sitagliptin e Metformina Sandoz Sitagliptin/ 50 mg/ Film-coated
Italy Sandoz GmbH Oral use
Film-coated
Italy Sandoz GmbH Sitagliptin Sandoz GmbH Sitagliptin 100 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Italy Sandoz SpA Atazanavi Sandoz Atazanavir 200 mg Capsule, hard Oral use
Italy Sandoz SpA Atazanavir Sandoz Atazanavir 300 mg Capsule, hard Oral use
Film-coated
Italy Sandoz SpA Darunavir Sandoz Darunavir 600 mg Oral use
tablet
Film-coated
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 109/248
Member Marketing
form administration
EEA holder
Film-coated
tablet
Film-coated
Italy Sandoz SpA Erlotinib Sandoz Erlotinib 100 mg Oral use
tablet
Film-coated
Italy Sandoz SpA Erlotinib Sandoz Erlotinib 150 mg Oral use
tablet
Aurobindo
Dapagliflozina e Metformina Dapagliflozin/ 5 mg / 850 Film-coated
Italy Pharma (Italia) Oral use
Aurobindo metformin mg tablet
S.r.l.
Aurobindo
Dapagliflozina e Metformina Dapagliflozin/ 5 mg/ 1000 Film-coated
Italy Pharma (Italia) Oral use
Aurobindo metformin mg tablet
S.r.l.
Aurobindo
Italy Pharma (Italia) Furosemide Aurobindo Italia Furosemide 500 mg Tablet Oral use
S.r.l.
Aurobindo
Film-coated
Italy Pharma (Italia) Teriflunomide Aurobindo Teriflunomide 14 mg Oral use
tablet
S.r.l.
Aurobindo
Film-coated
Italy Pharma (Italia) Trazodone Aurobindo Trazodone 100 mg Oral use
tablet
S.r.l.
Aurobindo
Film-coated
Italy Pharma (Italia) Trazodone Aurobindo Trazodone 150 mg Oral use
tablet
S.r.l.
DOC Generici Prolonged-
Italy Rovalo Ranolazine 375 mg Oral use
S.r.l. release tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 110/248
Member Marketing
form administration
EEA holder

Elpen
Prolonged-
Italy Pharmaceutical Ranolpen Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Kappler
Italy Pharma Betaistina Kapplerpharma Betahistine 8 mg Tablet Oral use
Consult GmbH
Kappler
Consult GmbH
Kappler
Consult GmbH
LaNova
Film-coated
Italy farmaceutici Dalafil Tadalafil 5 mg Oral use
tablet
S.r.l.
LaNova
Film-coated
tablet
S.r.l.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 111/248
Member Marketing
form administration
EEA holder
LaNova
Film-coated
tablet
S.r.l.
Prolonged-
Italy Sandoz SpA Ranolazina Sandoz Ranolazine 375 mg Oral use
release tablet
Prolonged-
release tablet
Prolonged-
release tablet
Accord Abacavir/Lamivudine Accord
Latvia Healthcare 600 mg/300 mg film-coated Oral use
B.V. tablets
AOP Orphan
Tadalafil AOP 20 mg film-coated Film-coated
Latvia Pharmaceutic Tadalafil 20 mg Oral use
tablets tablet
als GmbH
Emulsion for
Anesia 10 mg/ml emulsion for
Latvia Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
injection/infusion
infusion
Emulsion for
Anesia 20 mg/ml emulsion for
Latvia Baxter B.V. Propofol 20 mg/ ml injection/ Intravenous use
injection/infusion
infusion
Vildagliptin/Metformin ELVIM 50
Elvim, SIA, Vildagliptin/ 50 mg/ Film-coated
Latvia mg/1000 mg film-coated Oral use
Latvia metformin 1000 mg tablet
tablets
Elvim, SIA, Vildagliptin/Metformin ELVIM 50 Vildagliptin/ 50 mg/ Film-coated
Latvia Oral use
Latvia mg/850 mg film-coated tablets metformin 850 mg tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 112/248
Member Marketing
form administration
EEA holder
LV System
Latvia Service, Suphrex 12.5 mg hard capsules Sunitinib 12,5 mg Capsule, hard Oral use
Latvia
LV System
Latvia Service, Suphrex 50 mg hard capsules Sunitinib 50 mg Capsule, hard Oral use
Latvia
Mylan
Erlotinib Mylan 100 mg film- Film-coated
Latvia Pharmaceutic Erlotinib 100 mg Oral use
als Limited
Mylan
Latvia Pharmaceutic Erlotinib 150 mg Oral use
als Limited
Atazanavir Sandoz 200 mg hard
Latvia Sandoz d.d. Atazanavir 200 mg Capsule, hard Oral use
capsules
Atazanavir Sandoz 300 mg hard
Latvia Sandoz d.d. Atazanavir 300 mg Capsule, hard Oral use
capsules
Erlotinib Sandoz 100 mg film- Film-coated
Latvia Sandoz d.d. Erlotinib 100 mg Oral use
Erlotinib Sandoz 150 mg film- Film-coated
Latvia Sandoz d.d. Erlotinib 150 mg Oral use
Sitagliptin Sandoz 100 mg film- Film-coated
Latvia Sandoz d.d. Sitagliptin 100 mg Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 113/248
Member Marketing
form administration
EEA holder
Sitagliptin/Metformin
hydrochloride Sandoz 50 Sitagliptin/ 50 mg/ Film-coated
Latvia Sandoz d.d. Oral use
mg/1000 mg film-coated metformin 1000 mg tablet
tablets
Latvia Sandoz d.d. hydrochloride Sandoz 50 Oral use
mg/850 mg film-coated tablets
Sorafenib Sandoz 400 mg film- Film-coated
Latvia Sandoz d.d. Sorafenib 400 mg Oral use
Umedica
Latvia Netherlands Deferasirox 180 mg Oral use
film-coated tablets tablet
B.V.
Umedica
B.V.
Umedica
B.V.
Umedica
Pirfenidone Umedica 267 mg Film-coated
Latvia Netherlands Pirfenidone 267 mg Oral use
B.V.
Umedica
Pirfenidone Umedica 801 mg Film-coated
Latvia Netherlands Pirfenidone 801 mg Oral use
B.V.
Umedica
Ranolazine Umedica 375 mg Prolonged-
Latvia Netherlands Ranolazine 375 mg Oral use
prolonged-release tablets release tablet
B.V.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 114/248
Member Marketing
form administration
EEA holder
Umedica
B.V.
Umedica
B.V.
Unifarma, Atorvastatin Unifarma 10 mg Film-coated
Latvia Atorvastatin 10 mg Oral use
SIA, Latvia film-coated tablets tablet
Elpen
Raupresil 375 mg prolonged- Prolonged-
Latvia Pharmaceutical Ranolazine 375 mg Oral use
release tablets release tablet
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Hexal
Ranzolva 375 mg prolonged- Prolonged-
Latvia Aktiengesellsch Ranolazine 375 mg Oral use
aft
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 115/248
Member Marketing
form administration
EEA holder
Hexal
aft
Hexal
aft
Pharos
Pharmaceutical Nilotinib PharOS 150 mg hard
Latvia Nilotinib 150 mg Capsule, hard Oral use
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Pharmaceutical Nilotinib Viatris 200 mg hard
Oriented capsules
Services Ltd.
Pharos
Pharmaceutical Nilotinib Zentiva 150 mg hard
Oriented capsules
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 116/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical Nilotinib Zentiva 200 mg hard
Oriented capsules
Services Ltd.
Accord Abacavir/Lamivudine Accord
Lithuania Healthcare 600 mg/300 mg plėvele Oral use
B.V. dengtos tabletės
AOP Orphan
Tadalafil AOP 20 mg plėvele Film-coated
Lithuania Pharmaceutic Tadalafil 20 mg Oral use
dengtos tabletės tablet
als GmbH
Emulsion for
Anesia 10 mg/ml injekcinė ar
Lithuania Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
infuzinė emulsija
infusion
Emulsion for
Anesia 20 mg/ml injekcinė ar
Lithuania Baxter B.V. Propofol 20 mg/ml injection/ Intravenous use
infuzinė emulsija
infusion
Vildagliptin/Metformin
Elvim, SIA, hydrochloride ELVIM Vildagliptin/ 50 mg/ Film-coated
Lithuania Oral use
Latvia 50 mg/1000 mg plėvele metformin 1000 mg tablet
dengtos tabletės
Vildagliptin/Metformin
Elvim, SIA, hydrochloride ELVIM Vildagliptin/ 50 mg/ Film-coated
Lithuania Oral use
Latvia 50 mg/850 mg plėvele dengtos metformin 850 mg tablet
tabletės
Mylan
Erlotinib Mylan 100 mg plėvele Film-coated
Lithuania Pharmaceutic Erlotinib 100 mg Oral use
als Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 117/248
Member Marketing
form administration
EEA holder
Mylan
als Limited
Mylan
als Limited
Mylan
als Limited
Sitagliptin Sandoz 100 mg Film-coated
Lithuania Sandoz d.d. Sitagliptin 100 mg Oral use
plėvele dengtos tabletės tablet
Lithuania Sandoz d.d. Oral use
mg/1000 mg plėvele dengtos metformin 1000 mg tablet
tabletės
Lithuania Sandoz d.d. Oral use
mg/850 mg plėvele dengtos metformin 850 mg tablet
tabletės
Lithuania Sandoz d.d. Sorafenib 400 mg Oral use
Elpen
Raupresil 375 mg pailginto Prolonged-
Lithuania Pharmaceutical Ranolazine 375 mg Oral use
atpalaidavimo tabletės release tablet
Co. Inc.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 118/248
Member Marketing
form administration
EEA holder
Elpen
Co. Inc.
Elpen
Co. Inc.
Lithuania X-Etium 5mg film-coated tablet Linagliptin 5 mg Oral use
S.A. tablet
Ranzolva 375 mg pailginto Prolonged-
Lithuania Hexal AG Ranolazine 375 mg Oral use
Pharos
Lithuania Nilotinib 150 mg Capsule, hard Oral use
Oriented kietosios kapsulės
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 119/248
Member Marketing
form administration
EEA holder
Pharos
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
Luxembou C4 health Metformin C4 health 1000 mg Film-coated
Metformin 1000 mg Oral use
rg GmbH Filmtabletten tablet
Denk Pharma
Luxembou Tadalafil Denk 10 mg Film-coated
GmbH & Co. Tadalafil 10 mg Oral use
rg Filmtabletten tablet
KG
Denk Pharma
Luxembou Tadalafil Denk 2,5 mg Film-coated
GmbH & Co. Tadalafil 2,5 mg Oral use
KG
Denk Pharma
KG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 120/248
Member Marketing
form administration
EEA holder
Denk Pharma
KG
EG Efavirenz/ 600 mg/
Luxembou Efatriten 600 mg/200 mg/245 Film-coated
(Eurogenerics emtricitabine/ 200 mg/ Oral use
rg mg EG comprimés pélliculés tablet
) NV tenofovir 245 mg
EG
Luxembou Film-coated
(Eurogenerics Erlotinib EG Erlotinib 25 mg Oral use
rg tablet
) NV
EG
rg tablet
) NV
EG
rg tablet
) NV
EG
rg tablet
) NV
EG
Luxembou Lacosamid EG 100 mg Film-coated
(Eurogenerics Lacosamide 100 mg Oral use
rg comprimés pélliculés tablet
) NV
EG
rg Comprimé pelliculé tablet
) NV
EG
rg Comprimé pelliculé tablet
) NV
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 121/248
Member Marketing
form administration
EEA holder
EG
rg comprimés pelliculés tablet
) NV
EG
Luxembou Sorafenib EG 400 mg, Film-coated
(Eurogenerics Sorafenib 400 mg Oral use
rg comprimés pelliculés tablet
) NV
EG
(Eurogenerics Tadalafil EG Tadalafil 5 mg Oral use
rg tablet
) NV
EG
rg tablet
) NV
EG
rg tablet
) NV
Elpen
Luxembou Ranolazin beta 375 mg Prolonged-
Pharmaceutical Ranolazine 375 mg Oral use
rg Retardtabletten release tablet
Co. Inc.
Elpen
Co. Inc.
Elpen
Co. Inc.
Elpen
Luxembou Ranolazin Heumann 375 mg Prolonged-
Co. Inc.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 122/248
Member Marketing
form administration
EEA holder
Elpen
Co. Inc.
Elpen
Co. Inc.
Hexal
Luxembou RanolaHexal 375 mg Prolonged-
Aktiengesellsch Ranolazine 375 mg Oral use
aft
Hexal
aft
Hexal
aft
Hexal
Luxembou Ranzolva 375 mg Prolonged-
aft
Hexal
aft
Hexal
aft
Luxembou Ranolazin - 1 A Pharma 375 mg Prolonged-
Hexal AG Ranolazine 375 mg Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 123/248
Member Marketing
form administration
EEA holder

Kappler
Luxembou Betahistin Kappler 16 mg
Pharma Betahistine 16 mg Tablet Oral use
rg Tabletten
Consult GmbH
Kappler
rg Tabletten
Consult GmbH
Kappler
rg Tabletten
Consult GmbH
Phagecon -
Luxembou Modified-release
Consultoria Tabletten mit veränderter Trazodone 150 mg Oral use
rg tablet
Lda.
Phagecon -
Luxembou Modified-release
Consultoria Tabletten mit veränderter Trazodone 75 mg Oral use
rg tablet
Lda.
Pharos
Luxembou Pharmaceutical
Nilotinib Pharos 150 mg, gélules Nilotinib 150 mg Capsule, hard Oral use
rg Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 124/248
Member Marketing
form administration
EEA holder
Pharos
rg Oriented
Services Ltd.
Pharos
rg Oriented
Services Ltd.
Luxembou Nilotinib PharOS 200 mg tvrde
Viatris Limited Nilotinib 200 mg Capsule, hard Oral use
rg kapsule
Luxembou
Viatris Limited Nilotinib Viatris 150 mg, gélule Nilotinib 150 mg Capsule, hard Oral use
rg
Luxembou
rg
Luxembou
rg
Aurobindo
Pharma Bosentan Aurobindo 125mg Film-coated
Malta Bosentan 125 mg Oral use
(Malta) film-coated tablets tablet
Limited
Aurobindo
Pharma Bosentan Aurobindo 62.5mg Film-coated
Malta Bosentan 62,5 mg Oral use
(Malta) film-coated tablets tablet
Limited
Aurobindo
Olanzapina Aurobindo 10 mg
Pharma Orodispersible
Malta orodispersible Olanzapine Oral use
(Malta) 10 mg tablet
tablets
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 125/248
Member Marketing
form administration
EEA holder
Aurobindo
Malta orodispersible Olanzapine 15 mg Oral use
(Malta) tablet
tablets
Limited
Aurobindo
(Malta) tablet
tablets
Limited
Aurobindo
(Malta) tablet
tablets
Limited
Aurobindo
Malta Olanzapine 10 mg Tablet Oral use
(Malta) tablets
Limited
Aurobindo
(Malta) tablets
Limited
Aurobindo
Pharma Olanzapine Aurobindo 2.5 mg
Malta Olanzapine 2,5 mg Tablet Oral use
(Malta) tablets
Limited
Aurobindo
(Malta) tablets
Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 126/248
Member Marketing
form administration
EEA holder
Aurobindo
Malta Olanzapine Tablet Oral use
(Malta) tablets 5 mg
Limited
Aurobindo
Pharma Olanzapine Aurobindo 7.5 mg
Malta Olanzapine 7,5 mg Tablet Oral use
(Malta) tablets
Limited
Aurobindo
Olanzapine Oro PharmConsul Orodispersible
Malta Pharma Olanzapine 10 mg Oral use
10 mg Orodispersible tablets tablet
Limited
Aurobindo
Limited
Aurobindo
Limited
Aurobindo
Olanzapine Oro PharmConsul 5 Orodispersible
mg Orodispersible tablets tablet
Limited
Brillpharma
Malta (Ireland) Amlodipine 2.5mg Tablets Amlodipine 2,5 mg Tablet Oral use
Limited
Denk Pharma
Malta GmbH & Co. Vildagliptin Denk 50 mg tablets Vildagliptin 50 mg Tablet Oral use
KG
Anau 100 mg film-coated Film-coated
Malta Heaton k.s. Sitagliptin 100 mg Oral use
tablets tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 127/248
Member Marketing
form administration
EEA holder
Sipactimet 50 mg/1000 mg Sitagliptin/ 50 mg/ Film-coated

Malta Heaton k.s. Oral use
film-coated tablets metformin 1000 mg tablet
Sipactimet 50 mg/850 mg film- Sitagliptin/ 50 mg/ Film-coated
Malta Heaton k.s. Oral use
coated tablets metformin 850 mg tablet
Morningside
Mebeverine Hydrochloride Film-coated
Malta Healthcare Mebeverine 135 mg Oral use
135mg Film-coated Tablets tablet
(Malta) Ltd
Morningside
Mebeverine Hydrochloride IBS Film-coated
Malta Healthcare Mebeverine 135 mg Oral use
135mg Film-coated Tablets tablet
(Malta) Ltd
Pharmconsul Olanzapine PharmConsul 10 mg Orodispersible
Malta Olanzapine 10mg Oral use
s.r.o. tablets tablet
Pharmconsul Olanzapine PharmConsul 5 mg Orodispersible
Malta Olanzapine 5mg Oral use
s.r.o. tablets tablet
Pharos
Pharmaceutic Lapatinib PharOS 250 mg film- Film-coated
Malta Lapatinib 250 mg Oral use
al Oriented coated tablets tablet
Services Ltd.
Pharos
Sitagliptin / Metformin PharOS
Pharmaceutic Sitagliptin/ 50 mg/ Film-coated
Malta 50 mg/1000 mg film-coated Oral use
al Oriented metformin 1000 mg tablet
tablet
Services Ltd.
Pharos
Sitagliptin / Metformin PharOS
Pharmaceutic Sitagliptin/ 50 mg/ Film-coated
Malta 50 mg/850 mg film-coated Oral use
al Oriented metformin 850 mg tablet
tablet
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 128/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutic Sitagliptin PharOS 100 mg film- Film-coated
Malta Sitagliptin 100 mg Oral use
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
RIA Generics
Malta Colchicine 0.5mg Tablets Colchicine 0,5 mg Tablet Oral use
Limited
Aurobindo Dapaglifozin/Metformin
Dapagliflozin/ 5 mg / 850 Film-coated
Malta Pharma Hydrochloride Aurobindo 5 Oral use
metformin mg tablet
(Malta) Limited mg/850 mg film-coated tablets
Aurobindo Dapaglifozin/Metformin
Malta Pharma Hydrochloride Aurobindo 5 Oral use
metformin mg tablet
(Malta) Limited mg/850 mg film-coated tablets
Dapaglifozin/Metformin
Aurobindo
Hydrochloride Aurobindo Dapagliflozin/ 5 mg / 850 Film-coated
Malta Pharma Oral use
Pharma 5 mg/850 mg film- metformin mg tablet
(Malta) Limited
coated tablets
Dapaglifozin/Metformin
Aurobindo
Hydrochloride Aurobindo Dapagliflozin/ 5 mg / 850 Film-coated
Malta Pharma Oral use
Pharma 5 mg/850 mg film- metformin mg tablet
(Malta) Limited
coated tablets
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 129/248
Member Marketing
form administration
EEA holder
Morningside
Malta Healthcare Mercaptopurine 10 mg Tablets Mercaptopurine 10 mg Tablet Oral use
(Malta) Ltd.
Morningside
Malta Healthcare Mercaptopurine 50 mg Tablets Mercaptopurine 50 mg Tablet Oral use
(Malta) Ltd.
Pharos
Malta Nilotinib 150 mg Capsule, hard Oral use
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Oriented capsules
Services Ltd.
Pharos
Pharmaceutical Nilotinib/Viatris Capsules hard,
Oriented 150 mg/cap
Services Ltd.
Pharos
Pharmaceutical Nilotinib/Viatris Capsules hard,
Oriented 200 mg/cap
Services Ltd.
Film-coated
Malta Remedica Ltd. ViaremBlu Sildenafil 25 mg Oral use
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 130/248
Member Marketing
form administration
EEA holder
Film-coated
tablet
Film-coated
tablet
Torrent
Film-coated
Malta Pharma Pazopanib 200 mg Pazopanib 200 mg Oral use
tablet
(Malta) Ltd
Accord
Abacavir/Lamivudine Accord Abacavir/ 600 mg/ Film-coated
Norway Healthcare Oral use
600 mg/300 mg lamivudine 300 mg tablet
B.V.
Emulsion for
Norway Baxter B.V. Profast Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Norway Baxter B.V. Profast Propofol 20 mg/ ml injection/ Intravenous use
infusion
Brown & Burk
Norway Lymecyclin Brown & Burk Lymecycline 300 mg Capsule, hard Oral use
IR Limited
Morningside
Norway Healthcare Dinetrel Amantadine 100 mg Capsule, hard Oral use
(Malta) Ltd
Norway Mylan AB valsartan/ mg/ 12,5 Oral use
Norway Mylan AB valsartan/ mg/ 12,5 Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 131/248
Member Marketing
form administration
EEA holder
Amlodipine/
Norway Mylan AB valsartan/ Oral use
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Norway Mylan AB Vildagliptin Mylan Vildagliptin 50 mg Tablet Oral use
Amlodipine/ Valsartan/ Amlodipine/ 5 mg / 160
Film-coated
Norway Mylan AB Hydrochlorothia zide Mylan valsartan/ mg / 12,5 Oral use
tablet
Pharma hydrochlorothiazide mg
Amlodipine/ Valsartan/ Amlodipine/ 5 mg / 160
Film-coated
Norway Mylan AB Hydrochlorothia zide Mylan valsartan/ mg / 25 Oral use
tablet
Pharma hydrochlorothiazide mg
Amlodipine/ Valsartan/ Amlodipine/ 10 mg /
Film-coated
Norway Mylan AB Hydrochlorothia zide Mylan valsartan/ 160 mg / Oral use
tablet
Pharma hydrochlorothiazide 12,5 mg
Film-coated
tablet
Pharma hydrochlorothiazide 25 mg
Film-coated
tablet
Pharma hydrochlorothiazide 25 mg
Newbury
Film-coated
Norway Pharmaceutic Lapatinib Newbury Lapatinib 250 mg Oral use
tablet
als AB
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 132/248
Member Marketing
form administration
EEA holder
Efavirenz/ 600 mg/

Film-coated
Norway Sandoz A/S Padviram emtricitabine/ 200 mg/ Oral use
tablet
tenofovir 245 mg
Sitagliptin Film-coated
Norway Sandoz B.V. Sitagliptin 50 mg Oral use
Hexal tablet
Sitagliptin Film-coated
Norway Sandoz B.V. Sitagliptin 25 mg Oral use
Hexal tablet
Film-coated
Norway Sandoz B.V. Sitagliptin Hexal Sitagliptin 100 mg Oral use
tablet
2care4
Norway Bendatol Albendazole 400 mg Tablet Oral use
Generics ApS
Pharos
Pharmaceutical
Norway Nilotinib Pharos Nilotinib 50 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Norway Nilotinib Viatris Nilotinib 50 mg Capsule Oral use
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 133/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Norway Nilotinib Viatris Nilotinib 150 mg Capsule Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Norway Nilotinib Viatris Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
+pharma
Sitagliptin + Metformin Sitagliptin/ 50 mg/ Film-coated
Poland arzneimittel Oral use
hydrochloride +pharma metformin 850 mg tablet
gmbh
+pharma
Poland arzneimittel Oral use
hydrochloride +pharma metformin 1000 mg tablet
gmbh
+pharma
Film-coated
Poland arzneimittel Sitagliptin +pharma Sitagliptin 25 mg Oral use
tablet
gmbh
+pharma
Film-coated
tablet
gmbh
+pharma
Film-coated
tablet
gmbh
Accord
Healthcare Abacavir/ 600 mg/ Film-coated
Poland Abacavir + Lamivudine Accord Oral use
Polska Sp. z lamivudine 300 mg tablet
o.o.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 134/248
Member Marketing
form administration
EEA holder
Aflofarm
Farmacja Film-coated
Poland Profitadal Tadalafil 2,5 mg Oral use
Polska Sp. z tablet
o.o.
Aflofarm
Poland Profitadal Tadalafil 5 mg Oral use
Polska Sp. z tablet
o.o.
Aflofarm
Poland Profitadal Tadalafil 20 mg Oral use
Polska Sp. z tablet
o.o.
Aflofarm
Poland Tadalafil Inventum Tadalafil 10 mg Oral use
Polska Sp. z tablet
o.o.
Aurovitas
Pharma Film-coated
Poland Leflunomide Aurovitas Leflunomide 10 mg Oral use
Polska Sp. z tablet
o.o.
Aurovitas
Pharma Film-coated
Poland Leflunomide Aurovitas Leflunomide 15 mg Oral use
Polska Sp. z tablet
o.o.
Aurovitas
Pharma
Poland Olanzapine PharmConsul Olanzapine 5 mg Tablet Oral use
Polska Sp. z
o.o.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 135/248
Member Marketing
form administration
EEA holder
Aurovitas
Pharma
Poland Olanzapine PharmConsul Olanzapine 10 mg Tablet Oral use
Polska Sp. z
o.o.
Emulsion for
Poland Baxter B.V. Propofol Baxter Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Poland Baxter B.V. Propofol Baxter Propofol 20 mg/ml injection/ Intravenous use
infusion
Belupo lijekovi
Film-coated
Poland i kozmetika, Tadalafil Belupo Tadalafil 5 mg Oral use
tablet
d.d.
Belupo lijekovi
Film-coated
Poland i kozmetika, Tadalafil Belupo Tadalafil 20 mg Oral use
tablet
d.d.
Dr. Max
Poland Loperamid Dr. Max Loperamide 2 mg Capsule, hard Oral use
Pharma s.r.o.
Eugia Pharma
Film-coated
Poland (Malta) Anastrozole Eugia Anastrozole 1 mg Oral use
tablet
Limited
Poland Gerocilan Tadalafil 2,5 mg Oral use
GmbH tablet
Poland Gerocilan Tadalafil 5 mg Oral use
GmbH tablet
GmbH tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 136/248
Member Marketing
form administration
EEA holder

GmbH tablet
Glenmark
Poland Pharmaceutic Posaconazole Glenmark Posaconazole 40 mg/ ml Oral suspension Oral use
als s.r.o.
Mylan Ireland
Poland Posaconazole Mylan Posaconazole 40 mg/ ml Oral suspension Oral use
Limited
Neuraxpharm
Modified-release
Poland Arzneimittel Azoneurax Trazodone 75 mg Oral use
tablet
GmbH
Neuraxpharm
Modified-release
Poland Arzneimittel Azoneurax Trazodone 150 mg Oral use
tablet
GmbH
Pharmaselect
International
Poland Colchianova Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Przedsiębiorst
wo Produkcji
Film-coated
Poland Farmaceutycz Epilantin Lacosamide 50 mg Oral use
tablet
nej HASCO-
LEK S.A.
Przedsiębiorst
wo Produkcji
Film-coated
tablet
nej HASCO-
LEK S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 137/248
Member Marketing
form administration
EEA holder
Przedsiębiorst
wo Produkcji
Film-coated
tablet
nej HASCO-
LEK S.A.
Przedsiębiorst
wo Produkcji
Film-coated
tablet
nej HASCO-
LEK S.A.
Film-coated
Poland Sandoz GmbH Darunavir Sandoz Darunavir 600 mg Oral use
tablet
Film-coated
Poland Sandoz GmbH Darunavir Sandoz Darunavir 800 mg Oral use
tablet
Poland Sandoz GmbH Oral use
hydrochloride Sandoz metformin 850 mg tablet
Poland Sandoz GmbH Oral use
hydrochloride Sandoz metformin 1000 mg tablet
Film-coated
Poland Sandoz GmbH Sitagliptin Sandoz Sitagliptin 50 mg Oral use
tablet
Film-coated
Poland Sandoz GmbH Sitagliptin Sandoz Sitagliptin 100 mg Oral use
tablet
Film-coated
Poland Sandoz GmbH Sorafenib Sandoz Sorafenib 400 mg Oral use
tablet
Stada
Film-coated
Poland Arzneimittel Brastib Lapatinib 250 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 138/248
Member Marketing
form administration
EEA holder
Stada
Poland Arzneimittel Posaconazol Stada Posaconazole 40 mg/ml Oral suspension Oral use
AG
Stada
Film-coated
Poland Arzneimittel Sorafenib Stada Sorafenib 400 mg Oral use
tablet
AG
Poland Teva B.V. Posaconazole Teva Posaconazole 40 mg/ ml Oral suspension Oral use
Poland Vipharm S.A. Anvildis Vildagliptin 50 mg Tablet Oral use
Poland Vipharm S.A. Anvildis Duo Oral use
Poland Vipharm S.A. Anvildis Duo Oral use
Aurovitas
Poland Pharma Polska Xiglodia Oral use
metformin mg tablet
Sp. z o.o.
Aurovitas
Poland Pharma Polska Xiglodia Oral use
metformin mg tablet
Sp. z o.o.
Bluefish
Poland Pharmaceutical Sunitinib Bluefish Sunitinib 12,5 mg Capsule, hard Oral use
s AB
Bluefish
Poland Pharmaceutical Sunitinib Bluefish Sunitinib 25 mg Capsule, hard Oral use
s AB
Bluefish
Poland Pharmaceutical Sunitinib Bluefish Sunitinib 50 mg Capsule, hard Oral use
s AB
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 139/248
Member Marketing
form administration
EEA holder
Generis
Film-coated
Poland Farmacêutica, Teriflunomide Aurovitas Teriflunomide 14 mg Oral use
tablet
S.A.
Generis
Film-coated
Poland Farmacêutica, Trazodone Aurovitas Trazodone 100 mg Oral use
tablet
S.A.
Generis
Film-coated
Poland Farmacêutica, Trazodone Aurovitas Trazodone 150 mg Oral use
tablet
S.A.
Poland Medreg s.r.o. Betahistine Medreg Betahistine 24 mg Tablet Oral use
Nutra Essential
Poland Ibuprofen Winadol Ibuprofen 400 mg Capsule, soft Oral use
OTC, S.L.
PharmConsul Orodispersible
Poland Olanzapine Oro PharmConsul Olanzapine 5 mg Oral use
s.r.o. tablet
s.r.o. tablet
s.r.o. tablet
s.r.o. tablet
Pharos
Pharmaceutical
Poland Nilotinib PharOS Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 140/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Poland Nilotinib Viatris Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Poland Nilotinib Zentiva Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Poland Nilotinib Zentiva Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
US Pharmacia
Poland Recenum Racecadotril 100 mg Capsule, hard Oral use
Sp. z o.o.
Alter Pharma Phenoxymethylpeni Film-coated
Portugal Oxinep 660 mg Oral use
NV cillin tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 141/248
Member Marketing
form administration
EEA holder

NV cillin tablet
NV cillin tablet
Amdipharm
Portugal Ciprofibrato Amdipharm Ciprofibrate 100 mg Capsule Oral use
Ltd
Emulsion for
Portugal Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
Propofol Baxter
infusion
Emulsion for
Portugal Baxter B.V. Propofol 20 mg/ml injection/ Intravenous use
Propofol Baxter
infusion
Bluefish
Pharmaceutic
Portugal Sunitinib Bluefish Sunitinib 12,5 mg Capsule, hard Oral use
als AB
Bluefish
Pharmaceutic
Portugal Sunitinib Bluefish Sunitinib 25 mg Capsule, hard Oral use
als AB
Bluefish
Pharmaceutic
Portugal Sunitinib Bluefish Sunitinib 50 mg Capsule, hard Oral use
als AB
Ciclum Farma
Film-coated
Portugal Unipessoal, Tadalafil 5 mg Oral use
Tadalafil Ciclum tablet
Lda.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 142/248
Member Marketing
form administration
EEA holder
Ciclum Farma
Film-coated
Lda.
Ciclum Farma
Film-coated
Lda.
Clydesdale
Pharma
Film-coated
Portugal Portugal, Tadalafil Kosei Tadalafil 2,5 mg Oral use
tablet
Unipessoal
Lda.
Clydesdale
Pharma
Film-coated
Portugal Portugal, Tadalafil Kosei Tadalafil 5 mg Oral use
tablet
Unipessoal
Lda.
Clydesdale
Pharma
Film-coated
tablet
Unipessoal
Lda.
Clydesdale
Pharma
Film-coated
tablet
Unipessoal
Lda.
Portugal Genement Tadalafil 2,5 mg Oral use
S.A. tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 143/248
Member Marketing
form administration
EEA holder
Portugal Genement Tadalafil 5 mg Oral use
S.A. tablet
S.A. tablet
S.A. tablet
Generis
Portugal Farmacêutica, Atazanavir 150 mg Capsule, hard Oral use
Atazanavir Generis
S.A.
Generis
Portugal Farmacêutica, Atazanavir 200 mg Capsule, hard Oral use
Atazanavir Generis
S.A.
Generis
Amilorida + Hidroclorotiazida Amiloride/ 2,5 mg/ 25
Portugal Farmacêutica, Tablet Oral use
Generis hydrochlorothiazide mg
S.A.
Generis
Amilorida + Hidroclorotiazida Amiloride/ 5 mg/ 50
Portugal Farmacêutica, Tablet Oral use
Generis hydrochlorothiazide mg
S.A.
Generis
Film-coated
Portugal Farmacêutica, Anastrozol Generis Phar Anastrozole 1 mg Oral use
tablet
S.A.
Generis
Portugal Farmacêutica, Atazanavir Generis Atazanavir 300 mg Capsule, hard Oral use
S.A.
Generis
Film-coated
Portugal Farmacêutica, Bosentano Aurobindo Bosentan 62,5 mg Oral use
tablet
S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 144/248
Member Marketing
form administration
EEA holder
Generis
Film-coated
Portugal Farmacêutica, Bosentano Aurobindo Bosentan 125 mg Oral use
tablet
S.A.
Generis
Film-coated
Portugal Farmacêutica, Leflunomida Generis Leflunomide 10 mg Oral use
tablet
S.A.
Generis
Film-coated
Portugal Farmacêutica, Leflunomida Generis Leflunomide 15 mg Oral use
tablet
S.A.
Generis
Metformina + Dapagliflozina Dapagliflozin/ 5 mg / 850 Film-coated
Portugal Farmacêutica, Oral use
Generis metformin mg tablet
S.A.
Generis
Metformina + Dapagliflozina Dapagliflozin/ 5 mg/ 1000 Film-coated
Generis metformin mg tablet
S.A.
Generis
Prolonged-
Portugal Farmacêutica, Nevirapina Generis Nevirapine 400 mg Oral use
release tablet
S.A.
Generis
Portugal Farmacêutica, Olanzapine 10 mg Tablet Oral use
comprimidos
S.A.
Generis
comprimidos
S.A.
Generis
Olanzapina Aurobindo 2.5 mg
Portugal Farmacêutica, Olanzapine 2,5 mg Tablet Oral use
comprimidos
S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 145/248
Member Marketing
form administration
EEA holder
Generis
comprimidos
S.A.
Generis
Portugal Farmacêutica, Olanzapine Tablet Oral use
comprimidos 5 mg
S.A.
Generis
Olanzapina Aurobindo 7.5 mg
comprimidos
S.A.
Generis
Orodispersible
Portugal Farmacêutica, Olanzapina Aurobindo xx mg Olanzapine 5 mg Oral use
tablet
S.A.
Generis
Orodispersible
Portugal Farmacêutica, Olanzapina Aurobindo xx mg Olanzapine Oral use
10 mg tablet
S.A.
Generis
Orodispersible
tablet
S.A.
Generis
Orodispersible
tablet
S.A.
Generis
Olanzapina Aurovitas xx mg
comprimidos
S.A.
Generis
Portugal Farmacêutica, Olanzapine Tablet Oral use
comprimidos 5 mg
S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 146/248
Member Marketing
form administration
EEA holder
Generis
comprimidos
S.A.
Generis
comprimidos
S.A.
Generis
comprimidos
S.A.
Generis
comprimidos
S.A.
Generis
Olanzapina Aurovitas xx mg Orodispersible
Portugal Farmacêutica, Olanzapine 5 mg Oral use
orodispersables tablet
S.A.
Generis
S.A.
Generis
S.A.
Generis
S.A.
Generis
Portugal Farmacêutica, Olanzapina Generis Olanzapine 2,5 mg Tablet Oral use
S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 147/248
Member Marketing
form administration
EEA holder
Generis
Portugal Farmacêutica, Olanzapina Generis Olanzapine Tablet Oral use
5 mg
S.A.
Generis
Portugal Farmacêutica, Olanzapina Generis Olanzapine 7,5 mg Tablet Oral use
S.A.
Generis
Portugal Farmacêutica, Olanzapina Generis Olanzapine 10 mg Tablet Oral use
S.A.
Generis
S.A.
Generis
S.A.
Generis
Portugal Farmacêutica, Racecadotril Generis Racecadotril 100 mg Capsule Oral use
S.A.
Laboratórios
Portugal Limeciclina Atral Lymecycline 408 mg Capsule Oral use
Atral, S.A.
Laboratorios
Anova -
Portugal Produtos Tutecvi Vildagliptin 50 mg Tablet Oral use
Farmacêuticos
Lda
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 148/248
Member Marketing
form administration
EEA holder
LifeWell
Pharmaceutic
Portugal al & Vipam Vildagliptin 50 mg Tablet Oral use
Healthcare,
Lda.
LifeWell
Pharmaceutic
Vildagliptin/ 50 mg/ 850 Film-coated
Portugal al & Vipmin Oral use
metformin mg tablet
Healthcare,
Lda.
LifeWell
Pharmaceutic
Portugal al & Vipmin Oral use
Healthcare,
Lda.
Amlodipina + Valsartan + Film-coated
Portugal Mylan Lda valsartan/ mg/ 12,5 Oral use
Hidroclorotiazida Mylan tablet
Amlodipina + Valsartan + Film-coated
Portugal Mylan Lda valsartan/ mg/ 12,5 Oral use
Hidroclorotiazida Mylan tablet
Amlodipine/
Amlodipina + Valsartan + 5 mg/ 160 Film-coated
Portugal Mylan Lda valsartan/ Oral use
Hidroclorotiazida Mylan mg/ 25 mg tablet
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 149/248
Member Marketing
form administration
EEA holder
Amlodipine/
hydrochlorothiazide
Portugal Mylan Lda Vildagliptin Mylan Vildagliptin 50 mg Tablet Oral use
Mylan
Film-coated
Portugal Pharmaceutic Erlotinib Mylan Erlotinib 25 mg Oral use
tablet
als Limited
Mylan
Film-coated
Portugal Pharmaceutic Erlotinib Mylan Erlotinib 50 mg Oral use
tablet
als Limited
Portugal Mylan, Lda. Posaconazol Mylan Posaconazole 40 mg/ ml Oral suspension Oral use
Film-coated
Portugal Mylan, Lda. Erlotinib Mylan Erlotinib 100 mg Oral use
tablet
Film-coated
Portugal Mylan, Lda. Erlotinib Mylan Erlotinib 150 mg Oral use
tablet
Pharmaselect
International
Portugal Colcamexx Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Pharmaselect
International
Portugal Colchicine Ria 1 mg tabletten Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Sandoz
Film-coated
Portugal Farmacêutica, Darunavir Sandoz Darunavir 600 mg Oral use
tablet
Lda.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 150/248
Member Marketing
form administration
EEA holder
Sandoz
Darunavir Sandoz 800 mg – Film-coated
Portugal Farmacêutica, Darunavir 800 mg Oral use
Lda.
Sandoz
Film-coated
Portugal Farmacêutica, Erlotinib Sandoz Erlotinib 25 mg Oral use
tablet
Lda.
Sandoz
Film-coated
tablet
Lda.
Sandoz
Film-coated
tablet
Lda.
Sandoz
Metformina + Sitagliptina Sitagliptin/ 50 mg/ Film-coated
Sandoz metformin 1000 mg tablet
Lda.
Sandoz
Metformina + Sitagliptina Sitagliptin/ 50 mg/ Film-coated
Sandoz metformin 850 mg tablet
Lda.
Sandoz
Film-coated
Portugal Farmacêutica, Sitagliptina Sandoz Sitagliptin 100 mg Oral use
tablet
Lda.
Sandoz
Film-coated
tablet
Lda.
Sandoz
Film-coated
tablet
Lda.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 151/248
Member Marketing
form administration
EEA holder
Sandoz
Film-coated
Portugal Farmacêutica, Sorafenib Sandoz Sorafenib 400 mg Oral use
tablet
Lda.
Baroque
Portugal Healthcare, Cefuroxima Baroque Cefuroxime 250 mg Tablet Oral use
Lda
Baroque
Portugal Healthcare, Cefuroxima Baroque Cefuroxime 500 mg Tablet Oral use
Lda
Elpen
Prolonged-
Portugal Pharmaceutical Ranolpen Ranolazine 375 mg Oral use
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Elpen
Prolonged-
release tablet
Co. Inc.
Generis
Portugal Farmacêutica, Furosemida Generis Phar Furosemide 500 mg Tablet Oral use
S.A.
Generis
Film-coated
Portugal Farmacêutica, Teriflunomida Generis Teriflunomide 14 mg Oral use
tablet
S.A.
Generis
Film-coated
Portugal Farmacêutica, Trazodona Aurobindo Trazodone 100 mg Oral use
tablet
S.A.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 152/248
Member Marketing
form administration
EEA holder
Generis
Film-coated
Portugal Farmacêutica, Trazodona Aurobindo Trazodone 150 mg Oral use
tablet
S.A.
Generis
Film-coated
Portugal Farmacêutica, Trazodona Generis Phar Trazodone 100 mg Oral use
tablet
S.A.
Generis
Film-coated
Portugal Farmacêutica, Trazodona Generis Phar Trazodone 150 mg Oral use
tablet
S.A.
Generis Phar, Film-coated
Portugal Teriflunomida Generis Phar Teriflunomide 14 mg Oral use
Unipessoal Lda tablet
Pharos
Pharmaceutical
Portugal Nilotinib Mylan Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Portugal Nilotinib Mylan Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Portugal Nilotinib Pharos Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 153/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Portugal Nilotinib Zentiva Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Portugal Viatris Limited Nilotinib Mylan Nilotinib 200 mg Capsule, hard Oral use
Viatris Posaconazol Mylan 40 mg/ml
Romania Posaconazole 40 mg/ ml Oral suspension Oral use
Limited suspensie orala
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 154/248
Member Marketing
form administration
EEA holder
Emulsion for
Romania Baxter B.V. Profast Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Romania Baxter B.V. Profast Propofol 20 mg/ ml injection/ Intravenous use
infusion
Dr. Max
Romania Loperamid Dr.Max Loperamide 2 mg Capsule, hard Oral use
Pharma s.r.o.
Lannacher
Film-coated
Romania Heilmittel Gerocilan Tadalafil 2,5 mg Oral use
tablet
Ges.m.b.H.
Lannacher
Film-coated
Romania Heilmittel Gerocilan Tadalafil 5 mg Oral use
tablet
Ges.m.b.H.
Lannacher
Film-coated
tablet
Ges.m.b.H.
Lannacher
Film-coated
tablet
Ges.m.b.H.
Mylan
Film-coated
Romania Pharmaceutic Erlotinib Mylan Erlotinib 100 mg Oral use
tablet
als Limited
Mylan
Film-coated
Romania Pharmaceutic Erlotinib Mylan Erlotinib 150 mg Oral use
tablet
als Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 155/248
Member Marketing
form administration
EEA holder
Mylan
Romania Pharmaceutic Erlotinib 100 mg Oral use
als Limited
Mylan
als Limited
Mylan
comprimat filmate tablet
als Limited
Pharmaselect
International Colchicina Pharmacelect 0,5 mg
Romania Colchicine 0,5 mg Tablet Oral use
Beteiligungs comprimate
GmbH
Pharmaselect
International Colchicina Pharmacelect 1mg
Romania Colchicine 1 mg Tablet Oral use
GmbH
Pharmaselect
International Colchicina Pharmacelect 1mg
Romania Colchicine 1 mg Tablet Oral use
GmbH
Romania Sandoz S.R.L. Darunavir 400 mg Oral use
comprimate filmate tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 156/248
Member Marketing
form administration
EEA holder

Erlotinib Sandoz 100 mg Film-coated
Romania Sandoz S.R.L. Erlotinib 100 mg Oral use
Efavirenz/ 600 mg/
Padviram 600 mg/ 200 mg Film-coated
Romania Sandoz S.R.L. emtricitabine/ 200 mg/ Oral use
/245 mg comprimate filmate tablet
tenofovir 245 mg
Sitagliptin/ Metformin Sandoz
Romania Sandoz S.R.L. 50 mg/1000 mg comprimate Oral use
filmate
Sandoz S.R.L. Sitagliptina Sandoz 100 mg Film-coated
Romania Sitagliptin 100 mg Oral use
Romania comprimate filmate tablet
Romania Sandoz S.R.L. Sorafenib 400 mg Oral use
compimate filmate tablet
Sanofi Racecadotril Sanofi 100 mg
Romania Racecadotril 100 mg Capsule, hard Oral use
Romania SRL capsule
SC Sandoz Sitagliptina Sandoz 100 mg Film-coated
Romania Sitagliptin 100 mg Oral use
SRL, Romania comprimate filmate tablet
Abacavir/Lamivudina Stada 600 Abacavir/ 600 mg/ Film-coated
Romania Stada M&D Srl Oral use
mg/300 mg comprimate filmate lamivudine 300 mg tablet
Romania Stada M&D Srl Atazanavir Stada 150 mg Atazanavir 150 mg Capsule, hard Oral use
Romania Stada M&D Srl Atazanavir Stada 300 mg Atazanavir 300 mg Capsule, hard Oral use
Lapatinib Stada 250 mg Film-coated
Romania Stada M&D Srl Lapatinib 250 mg Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 157/248
Member Marketing
form administration
EEA holder
Lapatinib Stada 250 mg Film-coated

Romania Stada M&D Srl Lapatinib 250 mg Oral use
Revestad 20 mg comprimate Film-coated
Romania Stada M&D Srl Tadalafil 20 mg Oral use
filmate tablet
Sorafenib Stada 400 mg Film-coated
Romania Stada M&D Srl Sorafenib 400 mg Oral use
Posaconazol Viatris 40 mg/ml
Romania Viatris Limited Posaconazole 40 mg/ ml Oral suspension Oral use
suspensie oral
Film-coated
Romania Zentiva k.s. Asbima HCT valsartan/ mg/ 12,5 Oral use
tablet
Film-coated
Romania Zentiva k.s. Asbima HCT valsartan/ mg/ 12,5 Oral use
tablet
Romania Medreg s.r.o. Betahistine Medreg Betahistine 24 mg Tablet Oral use
Nutra Essential
Romania Ibuprofen Nutra Essential Ibuprofen 400 mg Capsule, soft Oral use
OTC, S.L.
Pharos
Pharmaceutical
Romania Nilotinib 150 mg capsule Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Romania Nilotinib 200 mg capsule Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 158/248
Member Marketing
form administration
EEA holder
Pharos
Romania Nilotinib 150 mg Capsule, hard Oral use
Oriented capsulă
Services Ltd.
Pharos
Services Ltd.
Pharos
Services Ltd.
AOP Orphan
Tadalafil AOP 20 mg filmom Film-coated
Slovakia Pharmaceutic Tadalafil 20 mg Oral use
obalené tablety tablet
als GmbH
Ardez
Film-coated
Slovakia Pharma, spol. Tadard Tadalafil 5 mg Oral use
tablet
s r.o.
Ardez
Film-coated
Slovakia Pharma, spol. Tadard Tadalafil 20 mg Oral use
tablet
s r.o.
Belupo lijekovi
MIDZA 100 mg filmom obalené Film-coated
Slovakia i kozmetika, Lacosamide 100 mg Oral use
tablety tablet
d.d.
Belupo lijekovi
tablety tablet
d.d.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 159/248
Member Marketing
form administration
EEA holder
Belupo lijekovi
tablety tablet
d.d.
Belupo lijekovi
tablety tablet
d.d.
Belupo lijekovi
Film-coated
Slovakia i kozmetika, Tadalafil Belupo Tadalafil 20 mg Oral use
tablet
d.d.
Dr. Max
Slovakia Loperamid Dr.Max Loperamide 2 mg Capsule, hard Oral use
Pharma s.r.o.
G.L. Pharma Gerocilan 10 mg filmom Film-coated
Slovakia Tadalafil 10 mg Oral use
GmbH obalené tablety tablet
G.L. Pharma Gerocilan 2,5 mg filmom Film-coated
Slovakia Tadalafil 2,5 mg Oral use
G.L. Pharma Gerocilan 20 mg filmom Film-coated
G.L. Pharma Gerocilan 5 mg filmom obalené Film-coated
GmbH tablety tablet
Anau 100 mg filmom obalené Film-coated
Slovakia Heaton k.s. Sitagliptin 100 mg Oral use
tablety tablet
Slovakia Heaton k.s. Oral use
filmom obalené tablety metformin 1000 mg tablet
Slovakia Heaton k.s. Oral use
Slovakia Erlotinib Mylan Erlotinib 100 mg Oral use
Limited tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 160/248
Member Marketing
form administration
EEA holder

Slovakia Erlotinib Mylan Erlotinib 150 mg Oral use
Limited tablet
Neuraxpharm
Film-coated
Slovakia Bohemia Arkvimma Lacosamide 50 mg Oral use
tablet
s.r.o.
Neuraxpharm
Film-coated
tablet
s.r.o.
Neuraxpharm
Film-coated
tablet
s.r.o.
Neuraxpharm
Film-coated
tablet
s.r.o.
Neuraxpharm
Modified-release
Slovakia Bohemia Azoneurax Trazodone 75 mg Oral use
tablet
s.r.o.
Neuraxpharm
Modified-release
Slovakia Bohemia Azoneurax Trazodone 150 mg Oral use
tablet
s.r.o.
Opella
Healthcare
Slovakia ENDITRIL 100 mg tvrdé kapsuly Racecadotril 100 mg Capsule, hard Oral use
Slovakia
s.r.o.,
Pharmaselect
International
Slovakia Colcamedin 0,5 mg tablety Colchicine 0,5 mg Tablet Oral use
Beteiligungs
GmbH
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 161/248
Member Marketing
form administration
EEA holder
Pharmaselect
International
Slovakia Colcamedin 1 mg tablety Colchicine 1 mg Tablet Oral use
Beteiligungs
GmbH
Pharmevid
Slovakia Sunitinib Pharmevid Sunitinib 12.5 mg Capsule, hard Oral use
s.r.o.
Pharmevid
Slovakia Sunitinib Pharmevid Sunitinib 25 mg Capsule, hard Oral use
s.r.o.
Pharmevid
Slovakia Sunitinib Pharmevid Sunitinib 50 mg Capsule, hard Oral use
s.r.o.
Sandoz Film-coated
Slovakia Sitagliptin Sandoz 100 mg Sitagliptin 100 mg Oral use
GmbH, tablet
Sandoz Film-coated
Slovakia Sitagliptin Sandoz 50 mg Sitagliptin 50 mg Oral use
GmbH, tablet
Sitagliptin/Metformin Sandoz 50
Sandoz Sitagliptin/ 50 mg/ Film-coated
Slovakia mg/1000 mg filmom obalené Oral use
GmbH, metformin 1000 mg tablet
tablety
Sitagliptin/Metformin Sandoz 50
Sandoz Sitagliptin/ 50 mg/ Film-coated
Slovakia mg/850 mg filmom obalené Oral use
GmbH, metformin 850 mg tablet
tablety
Sandoz
Film-coated
Slovakia Pharmaceutic Erlotinib Sandoz 100 mg Erlotinib 100 mg Oral use
tablet
als d.d.
Sandoz
Film-coated
Slovakia Pharmaceutic Erlotinib Sandoz 150 mg Erlotinib 150 mg Oral use
tablet
als d.d.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 162/248
Member Marketing
form administration
EEA holder
Sandoz
Film-coated
Slovakia Pharmaceutic Sorafenib Sandoz 400 mg Sorafenib 400 mg Oral use
tablet
als d.d.
Stada
Slovakia Arzneimittel Posakonazol Stada Posaconazole 40 mg/ml Oral suspension Oral use
AG
STADA
Film-coated
Slovakia Arzneimittel Erlotinib STADA 100 mg Erlotinib 100 mg Oral use
tablet
AG,
STADA
Film-coated
Slovakia Arzneimittel Erlotinib STADA 150 mg Erlotinib 150 mg Oral use
tablet
AG,
Slovakia Viatris Limited Tutecvi 50 mg Vildagliptin 50 mg Tablet Oral use
Slovakia Vipharm S.A. Anvildis Vildagliptin 50 mg Tablet Oral use
Anvildis Duo 50 mg/1 000 mg Vildagliptin/ 50 mg/ Film-coated
Slovakia Vipharm S.A. Oral use
Anvildis Duo 50 mg/850 mg Vildagliptin/ 50 mg/ Film-coated
Slovakia Vipharm S.A. Oral use
Xantis Pharma Film-coated
Slovakia Tadalafil Xantis Tadalafil 2,5 mg Oral use
Limited tablet
Slovakia Tadalafil Xantis Tadalafil 5 mg Oral use
Limited tablet
Limited tablet
Limited tablet
Slovakia Medreg s.r.o. Betahistine Medreg Betahistine 16 mg Tablet Oral use
Slovakia Medreg s.r.o. Betahistine Medreg Betahistine 24 mg Tablet Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 163/248
Member Marketing
form administration
EEA holder
Pharos
Pharmaceutical
Slovakia Nilotinib Egis Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical Nilotinib STADA 150 mg tvrdé
Slovakia Nilotinib 150 mg Capsule, hard Oral use
Oriented kapsuly
Services Ltd.
Pharos
Oriented kapsuly
Services Ltd.
Pharos
Oriented kapsuly
Services Ltd.
Slovakia Viatris Limited Nilotinib Viatris 150 mg Nilotinib 150 mg Capsule, hard Oral use
Slovakia Viatris Limited Nilotinib Viatris 200 mg Nilotinib 200 mg Capsule, hard Oral use
Slovakia Zentiva k.s. Nilotinib Zentiva Nilotinib 150 mg Capsule, hard Oral use
Slovakia Zentiva k.s. Nilotinib Zentiva Nilotinib 200 mg Capsule, hard Oral use
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 164/248
Member Marketing
form administration
EEA holder

Slovenia Awerkano valsartan/ mg/ 12,5 Oral use
d.o.o. tablet
Amlodipine/
Alkaloid - INT 5 mg/ 160 Film-coated
Slovenia Awerkano valsartan/ Oral use
d.o.o. mg/ 25 mg tablet
hydrochlorothiazide
Slovenia Awerkano valsartan/ mg/ 12,5 Oral use
d.o.o. tablet
Amlodipine/
hydrochlorothiazide
Amlodipine/
hydrochlorothiazide
Slovenia Losmorid Lacosamide 50 mg Oral use
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
d.o.o. tablet
AOP Orphan
Film-coated
Slovenia Pharmaceutic Tadalafil AOP Orphan Tadalafil 20 mg Oral use
tablet
als GmbH
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 165/248
Member Marketing
form administration
EEA holder
Emulsion for
Slovenia Baxter B.V. Anesia Propofol 10 mg/ml injection/ Intravenous use
infusion
Emulsion for
Slovenia Baxter B.V. Anesia Propofol 20 mg/ ml injection/ Intravenous use
infusion
Belupo lijekovi
Film-coated
Slovenia i kozmetika, Midza Lacosamide 50 mg Oral use
tablet
d.d.
Belupo lijekovi
Film-coated
tablet
d.d.
Belupo lijekovi
Film-coated
tablet
d.d.
Belupo lijekovi
Film-coated
tablet
d.d.
Belupo lijekovi
Film-coated
Slovenia i kozmetika, Tadalafil Belupo Tadalafil 5 mg Oral use
tablet
d.d.
Belupo lijekovi
Film-coated
Slovenia i kozmetika, Tadalafil Belupo Tadalafil 20 mg Oral use
tablet
d.d.
Prolonged-
Slovenia Hexal AG Ranzolva Ranolazine 375 mg Oral use
release tablet
Prolonged-
release tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 166/248
Member Marketing
form administration
EEA holder
Prolonged-
release tablet
Pharos
Pharmaceutical
Slovenia Nilotinib Pharmascience Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Slovenia Nilotinib Pharmascience Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Slovenia Nilotinib Pharos Nilotinib 50 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Pharos
Pharmaceutical
Oriented
Services Ltd.
Almus
Tramadol Almus 50 mg
Spain Farmaceutica Tramadol 50 mg Capsule, hard Oral use
capsulas duras EFG
S.A.U.
Bosentan Aurovitas 125 mg
Aurobindo Film-coated
Spain Comprimidos Recubiertos con Bosentan 125 mg Oral use
Pharma B.V. tablet
Pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 167/248
Member Marketing
form administration
EEA holder
Amilorida/Hidroclorotiazida
Aurovitas Amiloride/ 5 mg/ 50
Spain Aurovitas 5 mg/50 mg Tablet Oral use
Spain S.A.U. hydrochlorothiazide mg
ComprimidosEFG
Bosentan Aurovitas 62,5 mg
Aurovitas Film-coated
Spain Comprimidos Recubiertos con Bosentan 62,5 mg Oral use
Spain S.A.U. tablet
Pelicula EFG
Leflunomida Aurovitas 10 mg
Spain Comprimidos Recubiertos con Leflunomide 10 mg Oral use
Spain S.A.U. tablet
Pelicula EFG
Nevirapina Aurovitas 400 mg
Aurovitas Prolonged-
Spain Comprimidos de Liberacion Nevirapine 400 mg Oral use
Spain S.A.U. release tablet
Prolongada EFG
Aurovitas Olanzapina Aurovitas xx mg
Spain Olanzapine 2,5 mg Tablet Oral use
Spain S.A.U. comprimidos
Spain Olanzapine Tablet Oral use
Spain S.A.U. comprimidos 5 mg
Spain S.A.U. comprimidos 7,5 mg
Spain S.A.U. comprimidos 10 mg
Aurovitas Olanzapina Aurovitas xx mg Orodispersible
Spain Olanzapine 5 mg Oral use
Spain S.A.U. orodispersables tablet
Spain Olanzapine Oral use
Spain S.A.U. orodispersables 10 mg tablet
Spain Olanzapine 15 mg Oral use
Spain S.A.U. orodispersables tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 168/248
Member Marketing
form administration
EEA holder
Propofol Baxter 10 mg/ml Emulsion for

Spain Baxter B.V. Emulsion Inyectable y para Propofol 10 mg/ml injection/ Intravenous use
Perfusion EFG infusion
Propofol Baxter 20 mg/ml Emulsion for
Spain Baxter B.V. Emulsion Inyectable y para Propofol 20 mg/ ml injection/ Intravenous use
Perfusion EFG infusion
Eugia Pharma Anastrozol Aurovitas 1 mg
Film-coated
Spain (Malta) Comprimidos Recubiertos con Anastrozole 1 mg Oral use
tablet
Limited Pelicula EFG
Glenmark
Posaconazol Glenmark 40
Spain Arzneimittel Posaconazole 40 mg Oral suspension Oral use
mg/ml Suspension Oral EFG
GmbH
GP-Pharm, Acore 10 mg comprimidos Film-coated
Spain Tadalafil 10 mg Oral use
S.A. recubiertos con pelicula EFG tablet
LABORATORI Atazanavir Stada 200 mg
Spain Atazanavir 200 mg Capsule, hard Oral use
O STADA, S.L. Capsulas Duras EFG
LABORATORI Atazanavir Stada 300 mg
Spain Atazanavir 300 mg Capsule, hard Oral use
O STADA, S.L. Capsulas Duras EFG
Darunavir Stada 600 mg
LABORATORI Film-coated
Spain Comprimidos Recubiertos con Darunavir 600 mg Oral use
O STADA, S.L. tablet
Pelicula EFG
Darunavir Stada 800 mg
Spain Comprimidos Recubiertos con Darunavir 800 mg Oral use
Pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 169/248
Member Marketing
form administration
EEA holder
Lacosamida Stada 100 mg

Laboratorio Film-coated
Spain Comprimidos Recubiertos con Lacosamide 100 mg Oral use
Stada, S.L. tablet
Pelicula EFG
Stada, S.L. tablet
Pelicula EFG
Stada, S.L. tablet
Pelicula EFG
Stada, S.L. tablet
Pelicula EFG
Lapatinib Stada 250 mg
Spain Comprimidos Recubiertos con Lapatinib 250 mg Oral use
Pelicula EFG
Tadalafilo Stada 10 mg
Spain Comprimidos Recubiertos con Tadalafil 10 mg Oral use
Pelicula EFG
Spain Comprimidos Recubiertos con Tadalafil 20 mg Oral use
Pelicula EFG
Spain Comprimidos Recubiertos con Sorafenib 400 mg Oral use
Pelicula EFG
Amlodipino/Valsartan/Hidroclor
Amlodipine/
Laboratorios otiazida Cinfamed 10 mg/160 10 mg/ 160 Film-coated
Spain valsartan/ Oral use
Cinfa, S.A. mg/25 mg Comprimidos mg/ 25 mg tablet
hydrochlorothiazide
Recubiertos con Pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 170/248
Member Marketing
form administration
EEA holder
Amlodipine/
Laboratorios otiazida Cinfamed 10 mg/320 10 mg/ 320 Film-coated
Spain valsartan/ Oral use
Cinfa, S.A. mg/25 mg Comprimidos mg/ 25 mg tablet
hydrochlorothiazide
Laboratorios otiazida Cinfamed 5 mg/160 Film-coated
Spain valsartan/ mg/ 12,5 Oral use
Cinfa, S.A. mg/12,5 mg Comprimidos tablet
Sandoz Sorafenib Sandoz 400 mg
Film-coated
Spain Farmaceutica comprimidos recubiertos de Sorafenib 400 mg Oral use
tablet
S.A. pelicula
Laboratorios Safilo 10 mg comprimidos Film-coated
Q Pharma S.L. recubiertos de pelicula EFG tablet
Mabo Farma, Fexion 100 mg comprimidos Film-coated
Spain Sildenafil 100 mg Oral use
Mabo Farma, Fexion 50 mg comprimidos Film-coated
Spain Sildenafil 50 mg Oral use
Tadalafilo Mabo 10 mg
Mabo Farma, Film-coated
Spain comprimidos recubiertos con Tadalafil 10 mg Oral use
S.A. tablet
pelicula EFG
S.A. tablet
pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 171/248
Member Marketing
form administration
EEA holder
S.A. tablet
pelicula EFG
Pilocarpina Milstein 5 mg
Film-coated
Spain Milstein C.V. comprimidos recubiertos con Pilocarpine 5 mg Oral use
tablet
pelicula EFG
Mylan Amlodipine/ 10 mg/ 160
otiazida Mylan 10 mg/160 Film-coated
Spain Pharmaceutic valsartan/ mg/ 12,5 Oral use
mg/12,5 mg Comprimidos tablet
als, S.L. hydrochlorothiazide mg
Mylan Amlodipine/
otiazida Mylan 10 mg/160 10 mg/ 160 Film-coated
Spain Pharmaceutic valsartan/ Oral use
mg/25 mg Comprimidos mg/ 25 mg tablet
als, S.L. hydrochlorothiazide
Mylan Amlodipine/
otiazida Mylan 10 mg/320 10 mg/ 320 Film-coated
mg/25 mg Comprimidos mg/ 25 mg tablet
Mylan Amlodipine/ 5 mg/ 160
otiazida Mylan 5 mg/160 Film-coated
Spain Pharmaceutic valsartan/ mg/ 12,5 Oral use
mg/12,5 mg Comprimidos tablet
als, S.L. hydrochlorothiazide mg
Mylan Amlodipine/
otiazida Mylan 5 mg/160 mg/25 5 mg/ 160 Film-coated
mg Comprimidos Recubiertos mg/ 25 mg tablet
con Pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 172/248
Member Marketing
form administration
EEA holder
Pharmaselect
International Colcamexx 0,5 mg
Spain Colchicine 0,5 mg Tablet Oral use
Beteiligungs Comprimidos EFG
GmbH
Abacavir/Lamivudina Dr.
Reddy Pharma Reddys 600 mg/300 mg Abacavir/ 600 mg/ Film-coated
Spain Oral use
Iberia S.A. Comprimidos Recubiertos con lamivudine 300 mg tablet
Pelicula EFG
Efavirenz/Emtricitabina/Tenofov
ir Disoproxilo Dr Reddys 600 Efavirenz/ 600 mg/
Reddy Pharma Film-coated
Spain mg/200 mg/245 mg emtricitabine/ 200 mg/ Oral use
Iberia S.A. tablet
Comprimidos Recubiertos con tenofovir 245 mg
Pelicula EFG
Sandoz Darunavir Sandoz 600 mg
Film-coated
Spain Farmaceutica, Comprimidos Recubiertos con Darunavir 600 mg Oral use
tablet
S.A. Pelicula EFG
Sandoz Darunavir Sandoz 800 mg
Film-coated
Spain Farmaceutica, Comprimidos Recubiertos con Darunavir 800 mg Oral use
tablet
S.A. Pelicula EFG
Efavirenz/Emtricitabina/Tenofov
Sandoz ir Disoproxilo Sandoz 600 Efavirenz/ 600 mg/
Film-coated
Spain Farmaceutica, mg/200 mg/245 mg emtricitabine/ 200 mg/ Oral use
tablet
S.A. Comprimidos Recubiertos con tenofovir 245 mg
Pelicula EFG
Sandoz Erlotinib Sandoz 100 mg
Film-coated
Spain Farmaceutica, Comprimidos Recubiertos con Erlotinib 100 mg Oral use
tablet
S.A. Pelicula EFG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 173/248
Member Marketing
form administration
EEA holder

Film-coated
tablet
S.A. Pelicula EFG
Film-coated
tablet
S.A. Pelicula EFG
Umedica Deferasirox Umedica 3180 mg
Film-coated
Spain Netherlands Comprimidos Recubiertos con Deferasirox 180 mg Oral use
tablet
B.V. Pelicula EFG
Film-coated
tablet
B.V. Pelicula EFG
Film-coated
tablet
B.V. Pelicula EFG
Umedica Ranolazina Umedica 375 mg
Prolonged-
Spain Netherlands comprimidos de liberacion Ranolazine 375 mg Oral use
release tablet
B.V. prolongada EFG
Prolonged-
release tablet
B.V. prolongada EFG
Prolonged-
release tablet
B.V. prolongada EFG
Vegal
Carbamazepina Vegal 100 mg
Spain Farmaceutica Carbamazepine 100 mg Tablet Oral use
Comprimidos EFG
S.L.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 174/248
Member Marketing
form administration
EEA holder
Vegal
Comprimidos EFG
S.L.
Vegal
Comprimidos EFG
S.L.
Sitagliptina Sandoz
Sandoz
Farmaceutica 100 mg Film-coated
Spain Farmaceutica, Sitagliptin 100 mg Oral use
comprimidos recubiertos de tablet
S.A.
pelicula EFG
Sitagliptina Sandoz
Sandoz
S.A.
pelicula EFG
Sitagliptina Sandoz
Sandoz
S.A.
pelicula EFG
Sitagliptina/Metformina Sandoz
Sandoz
Farmaceutica 50 mg/1000 mg Sitagliptin/ 50 mg/ Film-coated
Spain Farmaceutica, Oral use
comprimidos recubiertos de metformin 1000 mg tablet
S.A.
pelicula EFG
Sitagliptina/Metformina Sandoz
Sandoz
Farmaceutica 50 mg/850 mg Sitagliptin/ 50 mg/ 850 Film-coated
Spain Farmaceutica, Oral use
comprimidos recubiertos de metformin mg tablet
S.A.
pelicula EFG
Vildagliptina Viatris 50 mg Film-coated
Spain Viatris Limited Vildagliptin 50 mg Oral use
comprimidos EFG tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 175/248
Member Marketing
form administration
EEA holder
Dapagliflozina/Metformina
Aurovitas Aurovitas 5 mg/1000 mg Dapagliflozin/ 5 mg/ 1000 Film-coated
Spain Oral use
Spain S.A.U. Comprimidos Recubiertos con metformin mg tablet
Pelicula EFG
Dapagliflozina/Metformina
Aurovitas Aurovitas 5 mg/850 mg Dapagliflozin/ 5 mg / 850 Film-coated
Spain Oral use
Spain S.A.U. Comprimidos Recubiertos con metformin mg tablet
Pelicula EFG
Trazadona Aurovitas 100 mg
Spain comprimidos recubiertos de Trazodone 100 mg Oral use
Spain S.A.U. tablet
pelicula EFG
Generis Teriflunomida Aurovitas 14 mg
Film-coated
Spain Farmacêutica, comprimidos recubiertos de Teriflunomide 14 mg Oral use
tablet
S.A. pelicula EFG
KAPPLER
PHARMA Betahistine Kappler 16 mg
Spain Betahistine 16 mg Tablet Oral use
CONSULT tablets
GMBH
KAPPLER
CONSULT tablets
GMBH
KAPPLER
CONSULT tablets
GMBH
Nutra Essential Ibuprofeno Winadol 400 mg
Spain Ibuprofen 400 mg Capsule, soft Oral use
OTC, S.L. Capsulas Blandas
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 176/248
Member Marketing
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Pharos
Pharmaceutical Nilotinib Pharos 150 mg capsula
Spain Nilotinib 150 mg Capsule, hard Oral use
Oriented dura EFG
Services Ltd.
Pharos
Oriented dura EFG
Services Ltd.
Pharos
Oriented dura EFG
Services Ltd.
Pharos
Pharmaceutical Prostib 150 mg capsula dura
Oriented EFG
Services Ltd.
Pharos
Pharmaceutical Prostib 200 mg capsula dura
Oriented EFG
Services Ltd.
UMEDICA Pirfenidona Umedica 267 mg
Film-coated
Spain NETHERLANDS comprimidos recubiertos de Pirfenidone 267 mg Oral use
tablet
B.V. pelicula
UMEDICA Pirfenidona Umedica 801 mg
Film-coated
Spain NETHERLANDS comprimidos recubiertos de Pirfenidone 801 mg Oral use
tablet
B.V. pelicula
Prolonged-
Spain Zentiva k.s. Zymela Ranolazine 375 mg Oral use
release tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 177/248
Member Marketing
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Prolonged-
release tablet
Prolonged-
release tablet
2care4
Sweden Lymelysal Lymecycline 300 mg Capsule, hard Oral use
Generics ApS
Accord
Sweden Healthcare Abacavir/Lamivudine Accord Oral use
B.V.
AOP Orphan
Film-coated
Sweden Pharmaceutic Tadalafil AOP Tadalafil 20 mg Oral use
tablet
als GmbH
Emulsion for
Sweden Baxter B.V. Profast Propofol 10 mg/ml injection/ Parenteral use
infusion
Emulsion for
Sweden Baxter B.V. Profast Propofol 20 mg/ml injection/ Parenteral use
infusion
Bluefish
Pharmaceutic
Sweden Sunitinib Bluefish Sunitinib 12,5 mg Capsule, hard Oral use
als AB
Bluefish
Pharmaceutic
Sweden Sunitinib Bluefish Sunitinib 25 mg Capsule, hard Oral use
als AB
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 178/248
Member Marketing
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Bluefish
Pharmaceutic
Sweden Sunitinib Bluefish Sunitinib 50 mg Capsule, hard Oral use
als AB
Brown & Burk

Sweden Lymecyklin Brown & Burk Lymecycline 300 mg Capsule, hard Oral use
IR Limited
Glenmark
Film-coated
Sweden Arzneimittel Erlotinib Glenmark Erlotinib 25 mg Oral use
tablet
GmbH
Glenmark
Film-coated
tablet
GmbH
Glenmark
Film-coated
tablet
GmbH
Morningside
Sweden Healthcare Dinetrel Amantadine 100 mg Capsule, hard Oral use
(Malta) Ltd
Newbury
Film-coated
Sweden Pharmaceutic Lapatinib Newbury Lapatinib 250 mg Oral use
tablet
als AB
Sweden Fenoximetylpenicillin Orifarm 800 mg Oral use
Sweden Fenoximetylpenicillin Orifarm 1g Oral use
Film-coated
Sweden Sandoz A/S Darunavir Sandoz Darunavir 600 mg Oral use
tablet
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 179/248
Member Marketing
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Film-coated
Sweden Sandoz A/S Darunavir Sandoz Darunavir 800 mg Oral use
tablet
Film-coated
Sweden Sandoz A/S Erlotinib Sandoz Erlotinib 25 mg Oral use
tablet
Film-coated
tablet
Film-coated
tablet
Efavirenz/ 600 mg/
Film-coated
Sweden Sandoz A/S Padviram emtricitabine/ 200 mg/ Oral use
tablet
tenofovir 245 mg
Stada
Sweden Arzneimittel Abacavir/Lamivudine Stada Oral use
AG
Stada
Sweden Arzneimittel Atazanavir Stada Atazanavir 200 mg Capsule, hard Oral use
AG
Stada
Sweden Arzneimittel Atazanavir Stada Atazanavir 300 mg Capsule, hard Oral use
AG
Stada
Film-coated
Sweden Arzneimittel Ciastad Tadalafil 20 mg Oral use
tablet
AG
Stada
Film-coated
Sweden Arzneimittel Darunavir Stada Darunavir 600 mg Oral use
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 180/248
Member Marketing
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Stada
Film-coated
Sweden Arzneimittel Darunavir Stada Darunavir 800 mg Oral use
tablet
AG
Film-coated
Sweden Arzneimittel Emtenef emtricitabine/ 200 mg/ Oral use
tablet
AG tenofovir 245 mg
Stada
Film-coated
Sweden Arzneimittel Erlotinib Stada Erlotinib 25 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
Sweden Arzneimittel Lacosamide Stada Lacosamide 50 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 181/248
Member Marketing
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Stada
Sweden Arzneimittel Posaconazole Stada Posaconazole 40 mg/ml Oral suspension Oral use
AG
Stada
Film-coated
Sweden Arzneimittel Tadalafil Stada Tadalafil 5 mg Oral use
tablet
AG
Stada
Film-coated
tablet
AG
Stada
Film-coated
tablet
AG
2care4
Sweden Bentadol (suggested name) Albendazole 400 mg Tablet Oral use
Generics ApS
Kappler
Betahistin Kappler (suggested
Sweden Pharma Betahistine 8 mg Tablet Oral use
name)
Consult GmbH
Kappler
name)
Consult GmbH
Kappler
name)
Consult GmbH
Pharos
Pharmaceutical
Sweden Nilotinib Pharos Nilotinib 150 mg Capsule, hard Oral use
Oriented
Services Ltd.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 182/248
Member Marketing
form administration
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Pharos
Pharmaceutical
Sweden Nilotinib Pharos Nilotinib 200 mg Capsule, hard Oral use
Oriented
Services Ltd.
Pharos
Pharmaceutical Nilotinib PharOS (suggested
Sweden Nilotinib 50 mg Capsule, hard Oral use
Oriented name)
Services Ltd.
Pharos
Oriented name)
Services Ltd.
Pharos
Oriented name)
Services Ltd.
The Accord Abacavir/Lamivudine Accord
Netherlan Healthcare 600 mg/300 mg, filmomhulde Oral use
ds B.V. tabletten
The
Amdipharm Ciprofibraat Amdipharm 100 mg
Netherlan Ciprofibrate 100 mg Tablet Oral use
Limited tabletten
ds
The AOP Orphan
Tadalafil AOP 20 mg Film-coated
Netherlan Pharmaceutic Tadalafil 20 mg Oral use
filmomhulde tabletten tablet
ds als GmbH
The Amiloride
Aurobindo Amiloride/ 2,5 mg/ 25
Netherlan HCl/Hydrochloorthiazide Auro Tablet Oral use
Pharma B.V. hydrochlorothiazide mg
ds 2,5 mg/25 mg, tabletten
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 183/248
Member Marketing
form administration
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The Amiloride
Aurobindo Amiloride/ 5 mg/ 50
Netherlan HCl/Hydrochloorthiazide Auro 5 Tablet Oral use
Pharma B.V. hydrochlorothiazide mg
ds mg/50 mg, tabletten
The
Aurobindo Atazanavir Aurobindo 150 mg,
Netherlan Atazanavir 150 mg Capsule, hard Oral use
Pharma B.V. harde capsules
ds
The
ds
The
ds
The
Aurobindo Bosentan Aurobindo 125 mg Film-coated
Netherlan Bosentan 125 mg Oral use
Pharma B.V. filmomhulde tabletten tablet
ds
The
Aurobindo Bosentan Aurobindo 62,5 mg Film-coated
Netherlan Bosentan 62,5 mg Oral use
ds
The
Aurobindo Leflunomide Aurobindo 10 mg, Film-coated
Netherlan Leflunomide 10 mg Oral use
ds
The
Aurobindo Nevirapine Aurobindo 400 mg, Prolonged-
Netherlan Nevirapine 400 mg Oral use
Pharma B.V. tabletten met verlengde afgifte release tablet
ds
The
Aurobindo Olanzapine Aurobindo 10 mg
Netherlan Olanzapine 10 mg Tablet Oral use
Pharma B.V. Tabletten
ds
Annex I
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Member Marketing
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The
ds
The
Aurobindo Olanzapine Aurobindo 2.5 mg
Netherlan Olanzapine 2,5 mg Tablet Oral use
ds
The
ds
The
Netherlan Olanzapine Tablet Oral use
Pharma B.V. Tabletten 5 mg
ds
The Emulsion for
Propofol Spiva 10 mg/ml,
Netherlan Baxter B.V. Propofol 10 mg/ml injection/ Intravenous use
emulsie voor injectie of infusie
ds infusion
The Emulsion for
Propofol Spiva 20 mg/ml,
Netherlan Baxter B.V. Propofol 20 mg/ml injection/ Intravenous use
emulsie voor injectie of infusie
ds infusion
The Brillpharma
Gabapentine Brillpharma 50
Netherlan (Ireland) Gabapentin 50 mg/ml Oral solution Oral use
mg/ml drank, suikervrij
ds Limited
The Brillpharma
Solifenacinesuccinaat
Netherlan (Ireland) Solifenacin 1 mg/ml Oral solution Oral use
Brillpharma 1 mg/ml drank
ds Limited
The
Centrafarm Deferasirox CF 900 mg, Film-coated
Netherlan Deferasirox 900 mg Oral use
B.V. filmomhulde tabletten tablet
ds
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 185/248
Member Marketing
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The Efavirenz/Emtricitabine/Tenofov Efavirenz/ 600 mg/

Centrafarm Film-coated
Netherlan irdisoproxil CF 600/200/245 emtricitabine/ 200 mg/ Oral use
B.V. tablet
ds mg, filmomhulde tabletten tenofovir 245 mg
The
Centrafarm Erlotinib CF 100 mg, Film-coated
Netherlan Erlotinib 100 mg Oral use
ds
The
Centrafarm Erlotinib CF 150 mg, Film-coated
ds
The
Centrafarm Erlotinib CF 25 mg, filmomhulde Film-coated
B.V. tabletten tablet
ds
The
Centrafarm Erlotinib CF 50 mg, filmomhulde Film-coated
B.V. tabletten tablet
ds
The Denk Pharma
Netherlan GmbH & Co. Tadalafil 10 mg Oral use
ds KG
The Denk Pharma
Tadalafil Denk 2,5 mg Film-coated
Netherlan GmbH & Co. Tadalafil 2,5 mg Oral use
ds KG
The Denk Pharma
ds KG
The Denk Pharma
ds KG
Annex I
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The Denk Pharma

Vildagliptine Denk 50 mg
Netherlan GmbH & Co. Vildagliptin 50 mg Tablet Oral use
tabletten
ds KG
The
DOC Generici Sitagliptine DOC Generici, 100 Film-coated
Netherlan Sitagliptin 100 mg Oral use
S.r.l. mg filmomhulde tabletten tablet
ds
The
ds
The
ds
The
DOC Generici hydrochloride DOC Generici Sitagliptin/ 50 mg/ Film-coated
Netherlan Oral use
S.r.l. 50mg/1000 mg, filmomhulde metformin 1000 mg tablet
ds
tabletten
The
DOC Generici hydrochloride DOC Generici Sitagliptin/ 50 mg/ Film-coated
Netherlan Oral use
S.r.l. 50mg/850 mg, filmomhulde metformin 850 mg tablet
ds
tabletten
The
G.L. Pharma Gerocilan 10 mg filmomhulde Film-coated
Netherlan Tadalafil 10 mg Oral use
GmbH tabletten tablet
ds
The
G.L. Pharma Gerocilan 2,5 mg filmomhulde Film-coated
Netherlan Tadalafil 2,5 mg Oral use
ds
Annex I
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Member Marketing
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The
ds
The
ds
The
G.L. Pharma Sorafenib G.L. 400 mg, Film-coated
Netherlan Sorafenib 400 mg Oral use
GmbH filmomhulde tabletten tablet
ds
The
Genepharm
Netherlan Egotux 12,5 mg harde capsules Sunitinib 12,5 mg Capsule, hard Oral use
S.A.
ds
The
Genepharm
Netherlan Egotux 25 mg harde capsules Sunitinib 25 mg Capsule, hard Oral use
S.A.
ds
The
Genepharm
Netherlan Egotux 37,5 mg harde capsules Sunitinib 37,5 mg Capsule, hard Oral use
S.A.
ds
The
Genepharm
Netherlan Egotux 50 mg harde capsules Sunitinib 50 mg Capsule, hard Oral use
S.A.
ds
The
Genericon hydrochloride Genericon 50 Sitagliptin/ 50 mg/ Film-coated
Netherlan Oral use
Pharma GmbH mg/1000 mg filmomhulde metformin 1000 mg tablet
ds
tabletten
Annex I
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Member Marketing
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The
Genericon hydrochloride Genericon 50 Sitagliptin/ 50 mg/ Film-coated
Netherlan Oral use
Pharma GmbH mg/850 mg filmomhulde metformin 850 mg tablet
ds
tabletten
The Glenmark Posaconazol Glenmark 40
Netherlan Arzneimittel mg/ml suspensie voor oraal Posaconazole 40 mg Oral suspension Oral use
ds GmbH gebruik
The
Anau 100 mg filmomhulde Film-coated
Netherlan Heaton k.s. Sitagliptin 100 mg Oral use
tabletten tablet
ds
The
Sipactimet 50mg/1000 mg, Sitagliptin/ 50 mg/ Film-coated
Netherlan Heaton k.s. Oral use
filmomhulde tabletten metformin 1000 mg tablet
ds
The
Sipactimet 50mg/850 mg, Sitagliptin/ 50 mg/ Film-coated
Netherlan Heaton k.s. Oral use
ds
The Maddox
Sitagla 100 mg filmomhulde Film-coated
Netherlan Pharma Swiss Sitagliptin 100 mg Oral use
tabletten tablet
ds B.V.
The Maddox
tabletten tablet
ds B.V.
The Maddox
tabletten tablet
ds B.V.
The Maddox
Sitaglamet 50 mg/1000 mg Sitagliptin/ 50 mg/ Film-coated
Netherlan Pharma Swiss Oral use
ds B.V.
Annex I
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Member Marketing
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The Maddox
Sitaglamet 50 mg/850 mg Sitagliptin/ 50 mg/ Film-coated
Netherlan Pharma Swiss Oral use
ds B.V.
The
Clemastine Milstein 1 mg,
Netherlan Milstein C.V. Clemastine 1 mg Tablet Oral use
tabletten
ds
The Mylan Amlodipine/ 10 mg/ 160
orthiazide Mylan 10 mg/160 Film-coated
Netherlan Pharmaceutic valsartan/ mg/ 12,5 Oral use
mg/12,5 mg filmomhulde tablet
ds als Limited hydrochlorothiazide mg
tabletten
The Mylan Amlodipine/
orthiazide Mylan 10 mg/160 10 mg/ 160 Film-coated
Netherlan Pharmaceutic valsartan/ Oral use
mg/25 mg filmomhulde mg/ 25 mg tablet
ds als Limited hydrochlorothiazide
tabletten
tabletten
The Mylan Amlodipine/ 5 mg/ 160
orthiazide Mylan 5 mg/160 Film-coated
Netherlan Pharmaceutic valsartan/ mg/ 12,5 Oral use
mg/12,5 mg filmomhulde tablet
ds als Limited hydrochlorothiazide mg
tabletten
tabletten
Annex I
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The Mylan
Erlotinib Mylan 100 mg, Film-coated
Netherlan Pharmaceutic Erlotinib 100 mg Oral use
ds als Limited
The Mylan
ds als Limited
The Mylan
ds als Limited
The Mylan
ds als Limited
The Mylan
Nortriptyline Mylan 10 mg, Film-coated
Netherlan Pharmaceutic Nortriptyline 10 mg Oral use
ds als Limited
The Mylan
Nortriptyline Mylan 25 mg, Film-coated
Netherlan Pharmaceutic Nortriptyline 25 mg Oral use
ds als Limited
Mylan
The
Pharmaceutic Nortriptyline Mylan 50 mg, Film-coated
Netherlan Nortriptyline 50 mg Oral use
als filmomhulde tabletten tablet
ds
Ltd
Pharos
The
Pharmaceutic Lapatinib PharOS 250 mg, Film-coated
Netherlan Lapatinib 250 mg Oral use
al Oriented filmomhulde tabletten tablet
ds
Services Ltd.
Annex I
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Member Marketing
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The
RIA Generics
Netherlan Colchicine Ria 0.5 mg tabletten Colchicine 0,5 mg Tablet Oral use
Limited
ds
The
RIA Generics
Netherlan Colchicine Ria 1 mg tabletten Colchicine 1 mg Tablet Oral use
Limited
ds
The
Netherlan Sandoz B.V. Atazanavir 100 mg Capsule, hard Oral use
harde capsules
ds
The
harde capsules
ds
The
harde capsules
ds
The
harde capsules
ds
The
harde capsules
ds
The
harde capsules
ds
The
harde capsules
ds
Annex I
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Member Marketing
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The
Netherlan Sandoz B.V. Darunavir 150 mg Oral use
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 193/248
Member Marketing
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EEA holder
The
ds
The
ds
The
ds
The Efavirenz/ 600 mg/
irdisoproxil Sandoz 600 Film-coated
Netherlan Sandoz B.V. emtricitabine/ 200 mg/ Oral use
mg/200 mg/245 mg, tablet
ds tenofovir 245 mg
filmomhulde tabletten
irdisoproxil Sandoz 600 mg/200 Film-coated
mg/245 mg, filmomhulde tablet
ds tenofovir 245 mg
tabletten
The
Netherlan Sandoz B.V. Erlotinib 100 mg Oral use
ds
The
ds
The
ds
Annex I
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Member Marketing
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mg, filmomhulde tabletten tablet
ds tenofovir 245 mg
ds tenofovir 245 mg
The
Sitagliptine Sandoz 100 mg, Film-coated
Netherlan Sandoz B.V. Sitagliptin 100 mg Oral use
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
Annex I
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Member Marketing
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The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The
ds
The Sitagliptine/Metformine HCl
Netherlan Sandoz B.V. Sandoz 50mg/1000 mg, Oral use
ds filmomhulde tabletten
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 196/248
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Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 197/248
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The
Sorafenib Sandoz 400 mg, Film-coated
Netherlan Sandoz B.V. Sorafenib 400 mg Oral use
ds
The Stada
Brastib 250 mg, filmomhulde Film-coated
Netherlan Arzneimittel Lapatinib 250 mg Oral use
tabletten tablet
ds AG
The Stada
Ciastad 20 mg filmomhulde Film-coated
Netherlan Arzneimittel Tadalafil 20 mg Oral use
tabletten tablet
ds AG
The Stada
Darunavir Stada 150 mg, Film-coated
Netherlan Arzneimittel Darunavir 150 mg Oral use
ds AG
The Stada
ds AG
The Stada
ds AG
The Stada
ds AG
The Stada
ds AG
The Stada
ds AG
Annex I
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Member Marketing
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The Stada
Deferasirox Stada 900 mg, Film-coated
Netherlan Arzneimittel Deferasirox 900 mg Oral use
ds AG
The Stada Efavirenz/ 600 mg/
Efatriten 600 mg/200 mg/245 Film-coated
Netherlan Arzneimittel emtricitabine/ 200 mg/ Oral use
ds AG tenofovir 245 mg
The Stada
Lacosamide Stada 100 mg, Film-coated
Netherlan Arzneimittel Lacosamide 100 mg Oral use
ds AG
The Stada
ds AG
The Stada
ds AG
The Stada
ds AG
The Stada
Lapatinib Stada 250 mg, Film-coated
ds AG
The Stada
Lapatinib Stada Arzneimittel AG Film-coated
250 mg, filmomhulde tabletten tablet
ds AG
The Stada
Sorafenib Stada Arzneimittel Film-coated
Netherlan Arzneimittel Sorafenib 400 mg Oral use
400 mg, filmomhulde tabletten tablet
ds AG
Annex I
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Member Marketing
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The Stada
Tadalafil Stada 10 mg, Film-coated
ds AG
The Stada
Tadalafil Stada 2,5 mg, Film-coated
Netherlan Arzneimittel Tadalafil 2,5 mg Oral use
ds AG
The Stada
ds AG
The Stada
ds AG
The
Ursodeoxycholzuur Teva 300 Ursodeoxycholic
Netherlan Teva B.V. 300 mg Tablet Oral use
mg, tabletten acid
ds
The
Ursodeoxycholzuur Teva 500 Ursodeoxycholic
Netherlan Teva B.V. 500 mg Tablet Oral use
mg, tabletten acid
ds
The
Deferasirox Teva 900 mg, Film-coated
Netherlan Teva GmbH Deferasirox 900 mg Oral use
ds
The Umedica
Carbamazepine Umedica 100
Netherlan Netherlands Carbamazepine 100 mg Tablet Oral use
mg, tabletten
ds B.V.
The Umedica
mg, tabletten
ds B.V.
Annex I
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Member Marketing
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The Umedica
mg, tabletten
ds B.V.
The Umedica
Netherlan Netherlands Deferasirox 180 mg Oral use
ds B.V.
The Umedica
ds B.V.
The Umedica
ds B.V.
The Umedica
Netherlan Netherlands Sildenafil 100 mg Oral use
ds B.V.
The Umedica
ds B.V.
The Umedica
ds B.V.
The Umedica
ds B.V.
The Umedica
Tadalafil Umedica 10 mg Film-coated
Netherlan Netherlands Tadalafil 10 mg Oral use
ds B.V.
Annex I
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The Umedica
ds B.V.
The Umedica
ds B.V.
The
Darunavir Zentiva 400 mg, Film-coated
Netherlan Zentiva k.s. Darunavir 400 mg Oral use
ds
The
ds
The
ds
The
Aurobindo Furosemide Aurobindo 500 mg,
Netherlan Furosemide 500 mg Tablet Oral use
Pharma B.V. tabletten
ds
The
Aurobindo Trazodon HCl Aurobindo 100 Film-coated
Netherlan Trazodone 100 mg Oral use
Pharma B.V. mg, filmomhulde tabletten tablet
ds
The
Netherlan Devatis GmbH Eltrombopag 12,5 mg Oral use
ds
The
Netherlan Devatis GmbH Eltrombopag 25 mg Oral use
ds
Annex I
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The
ds
The
ds
The Focus Care
Amantadine HCl 100 mg Focus
Netherlan Pharmaceutical Amantadine 100 mg Capsule, hard Oral use
Care, harde capsules
ds s B.V.
The Focus Care
Methotrexaat 2,5 mg Focus Film-coated
Netherlan Pharmaceutical Methotrexate 2,5 mg Oral use
Care, filmomhulde tabletten tablet
ds s B.V.
The
Genepharm Tadalafil/Genepharm 20 mg Film-coated
S.A. filmomhulde tablet tablet
ds
The Generis
Teriflunomide Aurobindo 14 mg, Film-coated
Netherlan Farmacêutica, Teriflunomide 14 mg Oral use
ds S.A.
The
Innovis Renofrin 375 mg, tablet met Prolonged-
Netherlan Ranolazine 375 mg Oral use
Pharma S.A. verlengde afgifte release tablet
ds
The
ds
The
ds
Annex I
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Member Marketing
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Pharos
The
Netherlan Nilotinib 150 mg Capsule, hard Oral use
Oriented capsules
ds
Services Ltd.
Pharos
The
Oriented capsules
ds
Services Ltd.
Pharos
The
Oriented capsules
ds
Services Ltd.
Pharos
The
Oriented capsules
ds
Services Ltd.
Pharos
The
Oriented capsules
ds
Services Ltd.
The Umedica
Oxcarbazepine Umedica 150 mg Film-coated
Netherlan Netherlands Oxcarbazepine 150 mg Oral use
ds B.V.
The Umedica
ds B.V.
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 204/248
Member Marketing
form administration
EEA holder
The Umedica
ds B.V.
The
Netherlan Viatris Limited Nilotinib 150 mg Capsule, hard Oral use
capsules
ds
The
Netherlan Viatris Limited Nilotinib 200 mg Capsule, hard Oral use
capsules
ds
United
Accord
Kingdom Trospium 20 mg film-coated Film-coated
Healthcare Trospium 20 mg Oral use
(Northern tablets tablet
Limited
Ireland)
United
Kingdom Accord UK Phenytoin Sodium NRIM 100
Phenytoin sodium 100 mg Capsule, hard Oral use
(Northern Limited mg capsules
Ireland)
United
Activase
Kingdom
Pharmaceutic Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern
als Limited
Ireland)
United
Activase
Kingdom
Pharmaceutic Carbimazole 5 mg tablets Carbimazole 5 mg Tablet Oral use
(Northern
als Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 205/248
Member Marketing
form administration
EEA holder
United Alissa
Kingdom Healthcare Nortriptyline 10 mg film-coated Film-coated
Nortriptyline 10 mg Oral use
(Northern Research tablets tablet
Ireland) Limited
United Alissa
Kingdom Healthcare Nortriptyline 25 mg film-coated Film-coated
(Northern Research tablets tablet
Ireland) Limited
United
Avianta
Kingdom Tadalafil 10 mg film-coated Film-coated
Pharma Tadalafil 10 mg Oral use
Limited
Ireland)
United
Avianta
Kingdom Tadalafil 2.5 mg film-coated Film-coated
Pharma Tadalafil 2,5 mg Oral use
Limited
Ireland)
United
Avianta
Limited
Ireland)
United
Avianta
Limited
Ireland)
United
Baxter Emulsion for
Kingdom Propofol 10 mg/ml emulsion for
Healthcare Propofol 10 mg/ml injection/ Intravenous use
(Northern injection/infusion
Limited infusion
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 206/248
Member Marketing
form administration
EEA holder
United
Baxter Emulsion for
Kingdom Propofol 20 mg/ml emulsion for
Healthcare Propofol 20 mg/ml injection/ Intravenous use
(Northern injection/infusion
Limited infusion
Ireland)
United
Kingdom BRILLPHARMA Amlodipine 1mg/ml, oral
Amlodipine 1 mg/ ml Oral solution Oral use
(Northern LIMITED solution
Ireland)
United
Kingdom Brillpharma Gabapentin 50 mg/ml oral
Gabapentin 50 mg/ ml Oral solution Oral use
(Northern Limited solution
Ireland)
United
Oxybutynin Hydrochloride
Kingdom Brillpharma 2,5 mg/ 5
Brillpharma 2,5 mg/ 5 ml oral Oxybutynin Oral solution Oral use
(Northern Limited ml
solution
Ireland)
United
Oxybutynin Hydrochloride
Kingdom Brillpharma
Brillpharma 5 mg/ 5 ml oral Oxybutynin 5 mg/ 5 ml Oral solution Oral use
(Northern Limited
solution
Ireland)
United
Kingdom Brillpharma Prednisolone 2,5 mg gastro- Gastro-resistant
Prednisolone 2,5 mg Oral use
(Northern Limited resitant tablets tablet
Ireland)
United
Kingdom Brillpharma Prednisolone 5 mg gastro- Gastro-resistant
Prednisolone 5 mg Oral use
(Northern Limited resitant tablets tablet
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 207/248
Member Marketing
form administration
EEA holder
United
Kingdom Brillpharma Solifenacin succinate 1 mg/ml
Solifenacin 1 mg/ ml Oral solution Oral use
(Northern Limited oral solution
Ireland)
United
Bristol
Kingdom Amlodipine Bristol Lab 2,5 mg
Laboratories Amlodipine 2,5 mg Tablet Oral use
(Northern tablets
Limited
Ireland)
United
Bristol
Kingdom Isosorbide
Laboratories Angitate 10 mg tablets 10 mg Tablet Oral use
(Northern mononitrate
Limited
Ireland)
United
Bristol
Kingdom Isosorbide
Limited
Ireland)
United
Bristol
Kingdom Isosorbide
Limited
Ireland)
United
Bristol
Kingdom Carbocisteine 375 mg capsules,
Laboratories Carbocisteine 375 mg Capsule, hard Oral use
(Northern hard
Limited
Ireland)
United
Bristol
Kingdom
Laboratories Hydrocortisone 10 mg tablets Hydrocortisone 10 mg Tablet Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 208/248
Member Marketing
form administration
EEA holder
United
Bristol
Kingdom
(Northern
Limited
Ireland)
United
Bristol
Kingdom
Laboratories Ibuprofen 200 mg soft capsules Ibuprofen 200 mg Capsule, soft Oral use
(Northern
Limited
Ireland)
United
Bristol
Kingdom Isosorbide Mononitrate 10 mg Isosorbide
Laboratories 10 mg Tablet Oral use
(Northern tablets mononitrate
Limited
Ireland)
United
Bristol
Limited
Ireland)
United
Bristol
Limited
Ireland)
United
Bristol Nitrofurantoin Bristol
Kingdom
Laboratories Laboratories 100 mg capsules, Nitrofurantoin 100 mg Capsule, hard Oral use
(Northern
Limited hard
Ireland)
United
Bristol Nitrofurantoin Bristol
Kingdom
Laboratories Laboratories 50 mg capsules, Nitrofurantoin 50 mg Capsule, hard Oral use
(Northern
Limited hard
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 209/248
Member Marketing
form administration
EEA holder
United
Bristol
Kingdom Olanzapine 10 mg film-coated Film-coated
Laboratories Olanzapine 10 mg Oral use
Limited
Ireland)
United
Bristol
Limited
Ireland)
United
Bristol
Kingdom Olanzapine 2,5 mg film-coated Film-coated
Laboratories Olanzapine 2,5 mg Oral use
Limited
Ireland)
United
Bristol
Limited
Ireland)
United
Bristol
Limited
Ireland)
United
Bristol
Kingdom Olanzapine 7,5 mg film-coated Film-coated
Laboratories Olanzapine 7,5 mg Oral use
Limited
Ireland)
United
Bristol
Kingdom Prednisolone 2,5 mg gastro- Gastro-resistant
Laboratories Prednisolone 2,5 mg Oral use
(Northern resitant tablets tablet
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 210/248
Member Marketing
form administration
EEA holder
United
Bristol
Kingdom Prednisolone 5 mg gastro- Gastro-resistant
Laboratories Prednisolone 5 mg Oral use
(Northern resitant tablets tablet
Limited
Ireland)
United
Bristol
Kingdom Trazodone Hydrochloride 100
Laboratories Trazodone 100 mg Capsule, hard Oral use
(Northern mg capsules, hard
Limited
Ireland)
United
Bristol
Kingdom Trazodone Hydrochloride 150 Film-coated
Laboratories Trazodone 150 mg Oral use
(Northern mg capsules, hard tablet
Limited
Ireland)
United
Bristol
Kingdom Trazodone Hydrochloride 50 mg
Laboratories Trazodone 50 mg Capsule, hard Oral use
(Northern capsules, hard
Limited
Ireland)
United
Kingdom Brown & Burk
Lymecycline 408 mg capsules Lymecycline 408 mg Capsule, hard Oral use
(Northern UK Limited
Ireland)
United
Kingdom Brown & Burk Nefopam Hydrochloride 30 mg Film-coated
Nefopam 30 mg Oral use
(Northern UK Limited film-coated tablets tablet
Ireland)
United
Kingdom Brown & Burk Phenoxymethylpenicillin 250 Phenoxymethylpeni Film-coated
250 mg Oral use
(Northern UK Limited mg film-coated tablets cillin tablet
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 211/248
Member Marketing
form administration
EEA holder
United
Kingdom Clydesdale Tadalafil 10 mg film-coated Film-coated
Tadalafil 10 mg Oral use
(Northern Pharma Ltd tablets tablet
Ireland)
United
Kingdom Clydesdale Tadalafil 2.5 mg film-coated Film-coated
Tadalafil 2,5 mg Oral use
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom Clydesdale
Vildagliptin 50 mg tablets Vildagliptin 50 mg Tablet Oral use
(Northern Pharma LTD
Ireland)
United
Crescent
Kingdom Atorvastatin 10 mg film-coated
Pharma Atorvastatin 10 mg Tablet Oral use
(Northern tablets
Limited
Ireland)
United
Crescent
(Northern tablets
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 212/248
Member Marketing
form administration
EEA holder
United
Crescent
(Northern tablets
Limited
Ireland)
United
Crescent
(Northern tablets
Limited
Ireland)
United
Crescent
Kingdom Carbamazepine Crescent 100
Pharma Carbamazepine 100 mg Tablet Oral use
(Northern mg tablets
Limited
Ireland)
United
Crescent
Limited
Ireland)
United
Crescent
Limited
Ireland)
United Dilacort 2,5 mg gastro-resistant
Crescent
Kingdom tablets Gastro-resistant
Pharma Prednisolone 2,5 mg Oral use
(Northern Prednisolone 2,5 mg gastro- tablet
Limited
Ireland) resitant tablets
United Dilacort 5 mg gastro-resistant
Crescent
Kingdom tablets Gastro-resistant
Pharma Prednisolone 5 mg Oral use
(Northern Prednisolone 5 mg gastro- tablet
Limited
Ireland) resitant tablets
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 213/248
Member Marketing
form administration
EEA holder
United
Crescent
Kingdom Lacosamide Crescent 100 mg Film-coated
Pharma Lacosamide 100 mg Oral use
(Northern film-coated tablets tablet
Limited
Ireland)
United
Crescent
Limited
Ireland)
United
Crescent
Limited
Ireland)
United
Crescent
Limited
Ireland)
United
Crescent
Kingdom Posaconazole Crescent 40
Pharma Posaconazole 40 mg/ ml Oral suspension Oral use
(Northern mg/ml oral suspension
Limited
Ireland)
United
Crescent
Kingdom Tadalafil Crescent 10 mg film- Film-coated
(Northern coated tablets tablet
Limited
Ireland)
United
Crescent
Kingdom Tadalafil Crescent 2.5 mg film- Film-coated
Pharma Tadalafil 2,5 mg Oral use
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 214/248
Member Marketing
form administration
EEA holder
United
Crescent
Limited
Ireland)
United
Crescent
Limited
Ireland)
United
Crescent
Kingdom Vildagliptin Crescent 50 mg
Pharma Vildagliptin 50 mg Tablet Oral use
(Northern tablets
Limited
Ireland)
United
Cygnus
Kingdom
Pharma Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Cygnus
Kingdom
Pharma Carbimazole 5 mg tablets Carbimazole 5 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Kingdom
Dawa Limited Loperamide 2 mg capsules Loperamide 2 mg Capsule, hard Oral use
(Northern
Ireland)
United
Kingdom Metronidazole 200 mg/ 5 ml 200 mg/ 5
Dawa Limited Metronidazole Oral suspension Oral use
(Northern oral suspencion ml
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 215/248
Member Marketing
form administration
EEA holder
United
Dawa Limited Trazodone 100 mg Capsule, hard Oral use
Ireland)
United
Dawa Limited Trazodone 50 mg Capsule, hard Oral use
Ireland)
United
Dr Reddy's Abacavir/ LamivudineE Dr.
Kingdom Abacavir/ 600 mg/ Film-coated
Laboratories Reddy's 600 mg/300 mg film- Oral use
(Northern lamivudine 300 mg tablet
(EU) Limited coated tablets
Ireland)
United
Dr Reddy's
Kingdom Atazanavir Dr. Reddy's 200 mg
Laboratories Atazanavir 200 mg Capsule, hard Oral use
(UK) Limited
Ireland)
United
Dr Reddy's
Kingdom Atazanavir Dr. Reddy's 300 mg
Laboratories Atazanavir 300 mg Capsule, hard Oral use
(UK) Limited
Ireland)
United
Dr Reddy's
Kingdom
Laboratories Dapsone 50 mg tablets Dapsone 50 mg Tablet Oral use
(Northern
(UK) Limited
Ireland)
United Efavirenz/ Emtricitabine/
Dr Reddy's Efavirenz/ 600 mg/
Kingdom Tenofovir Disoproxil Dr. Reddy's Film-coated
Laboratories emtricitabine/ 200 mg/ Oral use
(Northern 600 mg/200 mg/245 mg film- tablet
(UK) Limited tenofovir 245 mg
Ireland) coated tablets
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 216/248
Member Marketing
form administration
EEA holder
United
Dr Reddy's
Kingdom Posaconazole Dr. Reddy's 40
Laboratories Posaconazole 40 mg/ ml Oral suspension Oral use
(UK) Limited
Ireland)
United
Focus
Kingdom
Pharmaceutic Ciprofibrate 100 mg tablet Ciprofibrate 100 mg Tablet Oral use
(Northern
als Limited
Ireland)
United
Focus
Kingdom
Pharmaceutic Fluoxetine 60 mg capsules Fluoxetine 60 mg Capsule, hard Oral use
(Northern
als Limited
Ireland)
United
Kingdom Generics (UK) Erlotinib 100 mg film-coated Film-coated
Erlotinib 100 mg Oral use
(Northern Limited tablets tablet
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom GENERICS Erlotinib Mylan 150 mg film- Film-coated
(Northern (UK) LIMITED coated tablets tablet
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 217/248
Member Marketing
form administration
EEA holder
United
Kingdom Generics (UK) Nortriptyline 10 mg film-coated Film-coated
Ireland)
United
Ireland)
United
Ireland)
United
Genus
Kingdom Fesoterodine Fumarate Stada Prolonged-
Pharmaceutic Fesoterodine 4 mg Oral use
(Northern 4mg prolonged-release tablets release tablet
als Limited
Ireland)
United
Genus
Kingdom Fesoterodine Fumarate Stada Prolonged-
Pharmaceutic Fesoterodine 8 mg Oral use
(Northern 8mg prolonged-release tablets release tablet
als Limited
Ireland)
United Glenmark
Kingdom Pharmaceutic Erlotinib Glenmark 100 mg film- Film-coated
(Northern als Europe coated tablets tablet
Ireland) Limited
United Glenmark
Ireland) Limited
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 218/248
Member Marketing
form administration
EEA holder
United Glenmark
Ireland) Limited
United
Kent
Kingdom OTC Concepts Diarrhoea Relief
Pharmaceutic Loperamide 2 mg Capsule, hard Oral use
(Northern 2 mg capsules, hard
als Limited
Ireland)
United
Key
Kingdom Alimemazine Tartrate 10mg Film-coated
Pharmaceutic Alimemazine 10 mg Oral use
als Limited
Ireland)
United
Key
Kingdom
Pharmaceutic Ezetimibe 10mg tablets Ezetimibe 10 mg Tablet Oral use
(Northern
als Limited
Ireland)
United
Lyrus Life
Kingdom Nitrofurantoin 25 mg/5 ml Oral 25 mg/ 5
Sciences Nitrofurantoin Oral suspension Oral use
(Northern suspension ml
Limted
Ireland)
United
Lyrus Life
Kingdom Nitrofurantoin 50 mg/5 ml Oral 50 mg/ 5
Sciences Nitrofurantoin Oral suspension Oral use
(Northern suspension ml
Limted
Ireland)
United
Manx
Kingdom Amantadine Hydrochloride
Healthcare Amantadine 100 mg Capsule, hard Oral use
(Northern 100mg capsules, hard
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 219/248
Member Marketing
form administration
EEA holder
United
Kingdom Milpharm Anastrozole 1 mg film-coated Film-coated
Anastrozole 1 mg Oral use
Ireland)
United
Kingdom Milpharm Bosentan Milpharm 125 mg Film-coated
Bosentan 125 mg Oral use
(Northern Limited film-coated tablet tablet
Ireland)
United
Kingdom Milpharm Bosentan Milpharm 62,5 mg Film-coated
Bosentan 62,5 mg Oral use
(Northern Limited film-coated tablet tablet
Ireland)
United
Kingdom Milpharm Leflunomide 10 mg film-coated Film-coated
Leflunomide 10 mg Oral use
Ireland)
United
Kingdom Milpharm Nevirapine Milpharm 400 mg Prolonged-
Nevirapine 400 mg Oral use
(Northern Limited prolonged-release tablets release tablet
Ireland)
United
Kingdom Milpharm Olanzapine 10 mg Orodispersible
Olanzapine Oral use
(Northern Limited orodispersible tablets 10 mg tablet
Ireland)
United
Olanzapine 15 mg Oral use
(Northern Limited orodispersible tablets tablet
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 220/248
Member Marketing
form administration
EEA holder
United
(Northern Limited orodispersible tablets tablet
Ireland)
United
Kingdom Milpharm Olanzapine 5 mg orodispersible Orodispersible
Ireland)
United
Kingdom Milpharm Olanzapine Milpharm 10 mg
Olanzapine 10 mg Tablet Oral use
(Northern Limited tablets
Ireland)
United
Ireland)
United
Kingdom Milpharm Olanzapine Milpharm 2,5 mg
Olanzapine 2,5 mg Tablet Oral use
Ireland)
United
Ireland)
United
Olanzapine Tablet Oral use
(Northern Limited tablets 5 mg
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 221/248
Member Marketing
form administration
EEA holder
United
Kingdom Milpharm Olanzapine Milpharm 7,5 mg
Olanzapine 7,5 mg Tablet Oral use
Ireland)
United
Morningside
Healthcare Amantadine 100 mg Capsule, hard Oral use
Limited
Ireland)
United
Morningside
Kingdom Bolamyn SR 750 mg prolonged- Prolonged-
Healthcare Metformin 750 mg Oral use
(Northern release tablet release tablet
Limited
Ireland)
United
Morningside
Kingdom Carbimazole 10 mg tablets /
Healthcare Carbimazole 10 mg Tablet Oral use
(Northern Reduzol 10 mg tablets
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Kingdom Clindamycin 150 mg capsules,
Healthcare Clindamycin 150 mg Capsule, hard Oral use
(Northern hard
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 222/248
Member Marketing
form administration
EEA holder
United
Morningside
(Northern hard
Limited
Ireland)
United
Morningside
(Northern hard
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Dapsone 100 mg tablets Dapsone 100 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Dapsone 50 mg tablets Dapsone 50 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Dexamethasone 0,5 mg tablets Dexamethasone 0,5 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Dexamethasone 2 mg tablets Dexamethasone 2 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Doxepin 10 mg capsules Doxepin 10 mg Capsule, hard Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 223/248
Member Marketing
form administration
EEA holder
United
Morningside
Kingdom
(Northern
Limited
Ireland)
United
Morningside
Kingdom
(Northern
Limited
Ireland)
United
Morningside Hisone 10 mg dispersable
Kingdom
Healthcare tablets / Hydrocortisone 10 mg Hydrocortisone 10 mg Tablet Oral use
(Northern
Limited Dispersible Tablets
Ireland)
United
Morningside Hisone 20 mg dispersable
Kingdom
Healthcare tablets / Hydrocortisone 20 mg Hydrocortisone 20 mg Tablet Oral use
(Northern
Ireland)
United
Morningside Hisone 5 mg dispersable tablets
Kingdom
Healthcare / Hydrocortisone 5 mg Hydrocortisone 5 mg Tablet Oral use
(Northern
Ireland)
United
Morningside
Kingdom
Healthcare Hydrocortisone 10 mg tablets Hydrocortisone 10 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Hydrocortisone 20 mg tablets Hydrocortisone 20 mg Tablet Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 224/248
Member Marketing
form administration
EEA holder
United
Morningside
Kingdom Levomepromazine Maleate 100
Healthcare Levomepromazine 100 mg Tablet Oral use
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Kingdom Lymecycline 408 mg capsules,
Healthcare Lymecycline 408 mg Capsule, hard Oral use
(Northern hard
Limited
Ireland)
United
Morningside Prolonged-
Kingdom Marol 100 mg prolonged-
Healthcare Tramadol 100 mg release capsule, Oral use
(Northern release capsules
Limited hard
Ireland)
United
Limited hard
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 225/248
Member Marketing
form administration
EEA holder
United
Limited hard
Ireland)
United
Kingdom Marol 50 mg prolonged-release
(Northern capsules
Limited hard
Ireland)
United
Morningside
Kingdom Mebeverine Hydrochloride 135 Film-coated
Healthcare Mebeverine 135 mg Oral use
(Northern mg film-coated tablets tablet
Limited
Ireland)
United
Morningside
Kingdom Mebeverine Hydrochloride IBS Film-coated
Healthcare Mebeverine 135 mg Oral use
(Northern 135 mg film-coated tablets tablet
Limited
Ireland)
United
Morningside
Kingdom Metabet SR 750 mg prolonged- Prolonged-
Limited
Ireland)
United
Morningside
Kingdom Metformin 750 mg prolonged- Prolonged-
Limited
Ireland)
United
Morningside
Kingdom Metronidazole 200 mg/ 5 ml 200 mg/ 5
Healthcare Metronidazole Oral suspension Oral use
(Northern oral suspencion ml
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 226/248
Member Marketing
form administration
EEA holder
United
Morningside
Kingdom Posaconazole 40 mg/ml oral
Healthcare Posaconazole 40 mg/ ml Oral suspension Oral use
(Northern suspension
Limited
Ireland)
United
Morningside
Kingdom Sukkarto SR 750 mg prolonged- Prolonged-
Limited
Ireland)
United
Morningside Tramadol Hydrochloride Prolonged-
Kingdom
Healthcare Morningside 100 mg prolonged- Tramadol 100 mg release capsule, Oral use
(Northern
Limited release capsules hard
Ireland)
United
Kingdom
(Northern
Ireland)
United
Kingdom
(Northern
Ireland)
United
Kingdom
(Northern
Ireland)
United
Morningside
Kingdom
Healthcare Trifluoperazine 1 mg tablets Trifluoperazine 1 mg Tablet Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 227/248
Member Marketing
form administration
EEA holder
United
Morningside
Kingdom
(Northern
Limited
Ireland)
United
Morningside
Kingdom
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Vildagliptin 50 mg tablets Vildagliptin 50 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Neon
Kingdom Posaconazole 40 mg/ml oral
Healthcare Posaconazole 40 mg/ ml Oral suspension Oral use
(Northern suspension
Limited
Ireland)
United
Northumbria
Limited
Ireland)
United
Northumbria
Limited
Ireland)
United
Northumbria
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 228/248
Member Marketing
form administration
EEA holder
United
Noumed Life
Kingdom Alimemazine Tartrate 10mg Film-coated
Sciences Alimemazine 10 mg Oral use
Limited
Ireland)
United
Noumed Life
Kingdom Colchicine 500 micrograms
Sciences Colchicine 0,5 mg Tablet Oral use
(Northern tablets
Limited
Ireland)
United
Noumed Life
Kingdom Methocarbamol 750 mg film-
Sciences Methocarbamol 750 mg Tablet Oral use
(Northern coated tablet
Limited
Ireland)
United
Kingdom Relonchem Sildenafil 100 mg film-coated Film-coated
Sildenafil 100 mg Oral use
Ireland)
United
Kingdom Relonchem Sildenafil 50 mg film-coated Film-coated
Ireland)
United
Kingdom Ria Generics
Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Ria Generics
(Northern Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 229/248
Member Marketing
form administration
EEA holder
United
Kingdom Ria Generics Colchicine 500 micrograms
Colchicine 0,5 mg Tablet Oral use
Ireland)
United
Kingdom Sandoz Atazanavir Sandoz 100 mg
Atazanavir 100 mg Capsule, hard Oral use
(Northern Limited capsule, hard
Ireland)
United
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom Sandoz Darunavir Sandoz 600 mg film- Film-coated
Darunavir 600 mg Oral use
(Northern Limited coated tablets tablet
Ireland)
United
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 230/248
Member Marketing
form administration
EEA holder
United
Ireland)
United Efavirenz/ Emtricitabine/
Efavirenz/ 600 mg/
Kingdom Sandoz Tenofovir Disoproxil 600 Film-coated
emtricitabine/ 200 mg/ Oral use
(Northern Limited mg/200 mg/245 mg film-coated tablet
tenofovir 245 mg
Ireland) tablets
United
Kingdom Sandoz Erlotinib Sandoz 100 mg film- Film-coated
Ireland)
United
Ireland)
United
Ireland)
United Special
Kingdom Concept
Loperamide 2 mg capsule, hard Loperamide 2 mg Capsule, hard Oral use
(Northern Development
Ireland) (UK) Limited
United Special
Kingdom Concept
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 231/248
Member Marketing
form administration
EEA holder
United Special
Kingdom Concept Metformin 1000 mg film-coated Film-coated
(Northern Development tablet tablet
United Special
United Special
United Special
Prolonged-
Kingdom Concept
Tramadol 50 mg capsules Tramadol 50 mg release capsule, Oral use
hard
United
Kingdom Strandhaven
Dapsone 100 mg tablets Dapsone 100 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Strandhaven
Dapsone 50 mg tablets Dapsone 50 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Strandhaven
Lodiarex 2 mg capsules, hard Loperamide 2 mg Capsule, hard Oral use
(Northern Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 232/248
Member Marketing
form administration
EEA holder
United
Kingdom Strandhaven Midorine Hydrochloride 2,5 mg
Midodrine 2,5 mg Tablet Oral use
Ireland)
United
Kingdom Strandhaven Midorine Hydrochloride 5 mg
Midodrine 5 mg Tablet Oral use
Ireland)
United
Kingdom Strandhaven Pilocarpine Hydrochloride 5 mg Film-coated
Pilocarpine 5 mg Oral use
(Northern Limited film-coated tablets tablet
Ireland)
United
Kingdom Strandhaven Trazodone Hydrochloride 100
Trazodone 100 mg Capsule, hard Oral use
(Northern Limited mg capsules, hard
Ireland)
United
Kingdom Strandhaven Trazodone Hydrochloride 50 mg
(Northern Limited capsules, hard
Ireland)
United
Strides
Kingdom
Pharma UK Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Strides
Kingdom
Pharma UK Carbimazole 5 mg tablets Carbimazole 5 mg Tablet Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 233/248
Member Marketing
form administration
EEA holder
United
Kingdom Dipyridamole 200 mg/ 5ml oral 200 mg/ 5
Syri Limited Dipyridamole Oral suspension Oral use
(Northern solution ml
Ireland)
United
Kingdom Oxybutynin Hydrochloride 2,5 2,5 mg / 5
Syri Limited Oxybutynin Oral solution Oral use
(Northern mg/5 ml oral solution ml
Ireland)
United
Kingdom Oxybutynin Hydrochloride 5 5 mg / 5
Syri Limited Oxybutynin Oral solution Oral use
(Northern mg/5 ml oral solution ml
Ireland)
United
Kingdom Teva UK
Primbital 250 mg tablets Primidone 250 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Teva UK
Primbital 50 mg tablets Primidone 50 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Teva UK Ursodeoxycholic acid 150 mg Ursodeoxycholic
150 mg Tablet Oral use
(Northern Limited tablets acid
Ireland)
United
Kingdom Thornton & Deferasirox 900 mg film-coated Film-coated
Deferasirox 900 mg Oral use
(Northern Ross Limited tablets tablet
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 234/248
Member Marketing
form administration
EEA holder
United
Kingdom Thornton & Lacosamide Stada 100 mg film- Film-coated
Lacosamide 100 mg Oral use
(Northern Ross Limited coated tablets tablet
Ireland)
United
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom Thornton & Posaconazole Thornton & Ross
Posaconazole 40 mg/ml Oral suspension Oral use
(Northern Ross Limited 40 mg/ml oral suspension
Ireland)
United
Tillomed
Kingdom
Laboratories Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Tillomed
Kingdom
Laboratories Carbimazole 5 mg tablets Carbimazole 5 mg Tablet Oral use
(Northern
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 235/248
Member Marketing
form administration
EEA holder
United
Kingdom Umedica Sildenafil 100 mg film-coated Film-coated
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom Umedica Tadalafil 10 mg film-coated Film-coated
Ireland)
United
Ireland)
United
Ireland)
United
Kingdom Umedica Tadalafil Crescent 2.5 mg film- Film-coated
Tadalafil 2,5 mg Oral use
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 236/248
Member Marketing
form administration
EEA holder
United
Waymade PLC Trazodone 100 mg Capsule, hard Oral use
Ireland)
United
Waymade PLC Trazodone 50 mg Capsule, hard Oral use
Ireland)
United
Kingdom Zista Pharma
Acetazolamide 250 mg tablet Acetazolamide 250 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Zista Pharma Amantadine Hydrochloride
Amantadine 100 mg Capsule, hard Oral use
(Northern Limited 100mg capsules, hard
Ireland)
United
Kingdom Zista Pharma
Baclofen 10 mg tablets Baclofen 10 mg Tablet Oral use
(Northern Limited
Ireland)
United
Kingdom Zista Pharma Carbocisteine 375 mg capsules,
Carbocisteine 375 mg Capsule, hard Oral use
(Northern Limited hard
Ireland)
United
Kingdom Zista Pharma Trazodone Hydrochloride 100
(Northern Limited mg capsules, hard
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 237/248
Member Marketing
form administration
EEA holder
United
Kingdom Zista Pharma Trazodone Hydrochloride 50 mg
(Northern Limited capsules, hard
Ireland)
United
Activase
Kingdom Gabapentin 50 mg/ml oral
Pharmaceutical Gabapentin 50 mg/ ml Oral solution Oral use
(Northern solution
s Limited
Ireland)
United
Biovantic
Kingdom Betahistine Dihydrochloride 16
Limited
Ireland)
United
Biovantic
Limited
Ireland)
United
Biovantic
Limited
Ireland)
United
Kingdom BRILLPHARMA Amlodipine Bristol Lab 2.5mg
Amlodipine 2,5 mg Tablet Oral use
(Northern LIMITED tablets
Ireland)
United
Kingdom Brillpharma Ramipril 0.5 mg/ml oral
Ramipril 0,5 mg/ ml Oral solution Oral use
(Northern Limited solution
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 238/248
Member Marketing
form administration
EEA holder
United
Kingdom Brillpharma
Ramipril 1 mg/ml oral solution Ramipril 1 mg/ ml Oral solution Oral use
(Northern Limited
Ireland)
United
Bristol
Laboratories Amantadine 100 mg Capsule, hard Oral use
Limited
Ireland)
United
Bristol
Kingdom
Laboratories Brilloper 2 mg capsules, hard Loperamide 2 mg Capsule, hard Oral use
(Northern
Limited
Ireland)
United
Bristol
Kingdom Carbocisteine 375 mg capsules,
Laboratories Carbocisteine 375 mg Capsule, hard Oral use
(Northern hard
Limited
Ireland)
United
Bristol
Kingdom
Laboratories Hydrocortisone 2,5 mg tablets Hydrocortisone 2,5 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Bristol
Kingdom
(Northern
Limited
Ireland)
United
Bristol
Kingdom Loperamide Hydrochloride 2 mg
Laboratories Loperamide 2 mg Capsule, hard Oral use
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 239/248
Member Marketing
form administration
EEA holder
United
Bristol
Kingdom
Laboratories Nortriptyline 10 mg tablets Nortriptyline 10 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Bristol
Kingdom
Laboratories Nortriptyline 25 mg tablets Nortriptyline 25 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Cygnus
Kingdom
Pharma Loperamide 2 mg capsule, hard Loperamide 2 mg Capsule, hard Oral use
(Northern
Limited
Ireland)
United
Cygnus
Kingdom Tramadol Hydrochloride 50 mg
Pharma Tramadol 50 mg Capsule, hard Oral use
Limited
Ireland)
United
Cygnus
Pharma Trazodone 100 mg Capsule, hard Oral use
Limited
Ireland)
United
Cygnus
Pharma Trazodone 50 mg Capsule, hard Oral use
Limited
Ireland)
United
Dr Reddy's
Kingdom Ranolazine 375 mg prolonged- Prolonged-
Laboratories Ranolazine 375 mg Oral use
(Northern release tablets release tablet
(UK) Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 240/248
Member Marketing
form administration
EEA holder
United
Dr Reddy's
(UK) Limited
Ireland)
United
Dr Reddy's
(UK) Limited
Ireland)
United
Genus
Kingdom
Pharmaceutical Nilotinib 150 mg hard capsules Nilotinib 150 mg Capsule, hard Oral use
(Northern
s Limited
Ireland)
United
Genus
Kingdom
Pharmaceutical Nilotinib 200 mg hard capsules Nilotinib 200 mg Capsule, hard Oral use
(Northern
s Limited
Ireland)
United
Manx
Healthcare Betahistine 16 mg Tablet Oral use
Limited
Ireland)
United
Manx
Limited
Ireland)
United
Manx
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 241/248
Member Marketing
form administration
EEA holder
United
Dapagliflozin and Metformin
Kingdom Milpharm Dapagliflozin/ 5 mg/ 1000 Film-coated
hydrochloride 5mg/1000mg Oral use
(Northern Limited metformin mg tablet
film-coated tablets
Ireland)
United
Dapagliflozin and Metformin
Kingdom Milpharm Dapagliflozin/ 5 mg/ 850 Film-coated
hydrochloride 5mg/850mg film- Oral use
(Northern Limited metformin mg tablet
coated tablets
Ireland)
United
Kingdom Milpharm Dicycloverine Hydrochloride 10
Dicycloverine 10 mg Tablet Oral use
(Northern Limited mg tablets
Ireland)
United
Kingdom Milpharm Dicycloverine Hydrochloride 20
Ireland)
United
Kingdom Milpharm Teriflunomide 14 mg film- Film-coated
Teriflunomide 14 mg Oral use
Ireland)
United
Kingdom Milpharm
Topiramate 15 mg capsules Topiramate 15 mg Capsule, hard Oral use
(Northern Limited
Ireland)
United
Kingdom Milpharm
(Northern Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 242/248
Member Marketing
form administration
EEA holder
United
Kingdom Milpharm
(Northern Limited
Ireland)
United
Morningside
Kingdom Fludrocortisone Acetate 0,1 mg
Healthcare Fludrocortisone 0,1 mg Tablet Oral use
(Northern tablets
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Mercaptopurine 10 mg tablets Mercaptopurine 10 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom
Healthcare Mercaptopurine 50 mg tablets Mercaptopurine 50 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Morningside
Kingdom Pilocarpine Hydrochloride 5 mg Film-coated
Healthcare Pilocarpine 5 mg Oral use
Limited
Ireland)
United
Morningside
Healthcare Ranolazine 375 mg Oral use
Limited
Ireland)
United
Morningside
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 243/248
Member Marketing
form administration
EEA holder
United
Morningside
Limited
Ireland)
United
Morningside
Kingdom Sertraline 100 mg Film-coates Film-coated
Healthcare Sertraline 100 mg Oral use
(Northern Tablets tablet
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Limited
Ireland)
United
Morningside
Kingdom Tranylcypromine 10 mg film- Film-coated
Healthcare Tranylcypromine 10 mg Oral use
Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 244/248
Member Marketing
form administration
EEA holder
United
Noumed Life
Kingdom
Sciences Carbimazole 20 mg tablets Carbimazole 20 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Noumed Life
Kingdom
Sciences Carbimazole 5 mg tablets Carbimazole 5 mg Tablet Oral use
(Northern
Limited
Ireland)
United
Noumed Life
Kingdom Dutasteride 0.5 mg soft
Sciences Dutasteride 0,5 mg Capsule, soft Oral use
(Northern capsules
Limited
Ireland)
United
Noumed Life Ibuprofen 200 mg liquid
Kingdom
Sciences capsules / Ibuprofen 200 mg Ibuprofen 200 mg Capsule, soft Oral use
(Northern
Limited soft capsules
Ireland)
United
Noumed Life
Kingdom
Sciences Ibuprofen 400 mg soft capsules Ibuprofen 400 mg Capsule, soft Oral use
(Northern
Limited
Ireland)
United
Kingdom Perennial Montelukast 10 mg film-coated Film-coated
Montelukast 10 mg Oral use
Ireland)
United
Kingdom Relonchem
(Northern Limited
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 245/248
Member Marketing
form administration
EEA holder
United
Kingdom Relonchem
(Northern Limited
Ireland)
United
Kingdom Renata (UK) Dicycloverine Hydrochloride 10
Ireland)
United
Kingdom Renata (UK) Dicycloverine Hydrochloride 20
Ireland)
United
Rosemont
Kingdom Zonisamide Rosemont 20
Pharmaceutical Zonisamide 20 mg/ ml Oral suspension Oral use
s Limited
Ireland)
United
Kingdom Strandhaven
(Northern Limited
Ireland)
United
Kingdom Strandhaven
(Northern Limited
Ireland)
United
Kingdom Strandhaven Fludrocortisone Acetate 0,1 mg
Fludrocortisone 0,1 mg Tablet Oral use
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 246/248
Member Marketing
form administration
EEA holder
United
Kingdom Strandhaven Nitrofurantoin 100 mg capsules,
Nitrofurantoin 100 mg Capsule, hard Oral use
Ireland)
United
Kingdom Strandhaven Nitrofurantoin 50 mg capsules,
Nitrofurantoin 50 mg Capsule, hard Oral use
Ireland)
United
Kingdom Strandhaven
Timolol 10mg tablets Timolol 10 mg Tablet Oral use
(Northern Limited
Ireland)
United
Torrent
Kingdom Pazopanib Torrent 200 mg film- Film-coated
Pharma (UK) Pazopanib 200 mg Oral use
(Northern coated tablet tablet
Limited
Ireland)
United
Kingdom Umedical Ranolizine 375 mg prolonged- Prolonged-
Ranolazine 375 mg Oral use
(Northern Limited release tablets release tablet
Ireland)
United
Ireland)
United
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 247/248
Member Marketing
form administration
EEA holder
United
Zentiva
Kingdom Zirana 375 mg prolonged- Prolonged-
Pharma UK Ranolazine 375 mg Oral use
Limited
Ireland)
United
Zentiva
Limited
Ireland)
United
Zentiva
Limited
Ireland)
United
Lyrus Life
Kingdom
Sciences Lymecycline 408mg capsule Lymecycline 408 mg Capsule, hard Oral use
(Northern
Limted
Ireland)
United
Lyrus Life
Kingdom Mebeverine Hydrochloride
Sciences Mebeverine 135 mg Tablet Oral use
(Northern 135mg tablets
Limted
Ireland)
Annex I
EMA/338956/2023 Rev. 4 Corr. 1 Page 248/248

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21 March 2024

EMA/338956/2023 Rev. 4 Corr. 11

List of the names, pharmaceutical forms, strengths of the medicinal

Referral under Article 31 of Directive 2001/83/EC

Procedure number: EMEA/H/A-31/1529

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

G.L. Pharma Film-coated

Stada Lacosamid STADA 150 mg Film-coated

Aurobindo Leflunomide AB - 10 mg - Film- Film-coated

Brown & Burk

Sandoz - SA- Erlotinib Sandoz - 100 mg - Film-coated

G.L. Pharma Film-coated

Alkaloid - INT Losmorid 100 mg filmom Film-coated

ViaremBlu 50 mg filmom Film-coated

Erlotinib Remedica tablet, film- Film-coated

Czech Sitagliptin/Metformin Sandoz Sitagliptin/ 50 mg/ Film-coated

Czech Win Medica Amlodipine/ 5 mg/ 300 Film-coated

Czech Nutra Essential

Sitagliptin/ Metformin Sitagliptin/ 50 mg/ Film-coated

Atazanavir Biogaran 200 mg,

Vildagliptin Viatris 50 mg, Film-coated

Aliud Pharma Darunavir AL 400 mg Film-coated

Efavirenz/ emtricitabine/ Efavirenz/ 600 mg /

C4 health Metformin C4 health 1000 mg Film-coated

Elpen Amlodipin/Valsartan/Hydrochlor Amlodipine/

Atazanavir HEXAL 200 mg

Sorafenib HEXAL 400 mg Film-coated

Stadapharm Lacosamid Stada 200 mg Film-coated

Aurobindo Dapagliflozin/ Metformin

Umedica Dimethyl Fumarat Umedica 120

Amlodipine/ 5 mg/ 160

Sitagliptin/ 50 mg/ Film-coated

Win Medica Prolonged-

Genepharm Posaconazole Genepharm 40

Nilotinib Viatris 50 mg kemény

Italy EG SpA Posaconazolo EG Posaconazole 40 mg/ml Oral suspension Oral use

DOC Generici Prolonged-

Luxembou Ranolazin - 1 A Pharma 750 mg Prolonged-

Sipactimet 50 mg/1000 mg Sitagliptin/ 50 mg/ Film-coated

Efavirenz/ 600 mg/

G.L. Pharma Film-coated

Alter Pharma Phenoxymethylpeni Film-coated

Darunavir Sandoz 800 mg Film-coated

Lapatinib Stada 250 mg Film-coated

Mylan Ireland Film-coated

Amlodipine/ 5 mg/ 160

Propofol Baxter 10 mg/ml Emulsion for

Lacosamida Stada 100 mg

Sandoz Erlotinib Sandoz 150 mg

Brown & Burk

The Efavirenz/Emtricitabine/Tenofov Efavirenz/ 600 mg/

The Denk Pharma

The Efavirenz/ 600 mg/

The Sitagliptine/Metformine HCl

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