CMDh/305/2013

March 2018, Rev.02

Summary Public Assessment Report

Generics

Sitagliptin/Metformin Galenicum Health 50 mg/850

mg film-coated tablets
Sitagliptin/Metformin Galenicum Health 50 mg/1000
mg film-coated tablets
Sitagliptin Hydrochloride Monohydrate
Metformin Hydrochloride

MT/H/0373/001-2/DC

Date: March 2022

Summary PAR – Generics 1/15

 Summary Public Assessment Report

Generics
Sitagliptin/Metformin Galenicum Health 50 mg/850 mg film coated tablets
Sitagliptin/Metformin Galenicum Health 50 mg/1000 mg film coated tablets

Sitagliptin and Metformin hydrochloride, film coated tablet, 50 mg/850 mg and 50 mg/1000
mg

This is a summary of the public assessment report (PAR) for Sitagliptin/Metformin

Galenicum Health. It explains how Sitagliptin/Metformin Galenicum Health was assessed and
its authorisation recommended as well as its conditions of use. It is not intended to provide
practical advice on how to use Sitagliptin/Metformin Galenicum Health.

For practical information about using Sitagliptin/Metformin Galenicum Health, patients

should read the package leaflet or contact their doctor or pharmacist.

What is Sitagliptin/Metformin Galenicum Health and what is it used for?

Sitagliptin/Metformin Galenicum Health is a ‘generic medicine’. This means that

Sitagliptin/Metformin Galenicum Health is similar to a ‘reference medicine’ already
authorised in the European Union (EU) called Janumet 50 mg/850 mg film coated tablets and
Janumet 50 mg/1000 mg film coated tablets by Merck Sharp & Dohme B.V. registered in the
community since July 2008.

Sitagliptin/Metformin Galenicum Health can be used along with diet and exercise to help
lower blood sugar. This medicine can be used alone or with certain other medicines for
diabetes (insulin, sulphonylureas, or glitazones).

How does Sitagliptin/Metformin Galenicum Health work?

Sitagliptin/Metformin Galenicum Health contains two different medicines called sitagliptin

and metformin.
• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors)
• metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes
called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin
produced after a meal and lowers the amount of sugar made by the body.

How is Sitagliptin/Metformin Galenicum Health used?

The pharmaceutical form of Sitagliptin/Metformin Galenicum Health is film coated tablet and
the route of administration is oral. The recommended dose is one film coated tablet twice a
day, taken with meals in order to decrease the chance of stomach upset.

Please read section 3 of the PL for detailed information on dosing recommendations, the route
of administration, and the duration of treatment.

The medicine can only be obtained with a prescription.

Summary PAR – Generics 2/15

What benefits of Sitagliptin/Metformin Galenicum Health have been shown in studies?

Because Sitagliptin/Metformin Galenicum Health is a generic medicine, studies in patients

have been limited to tests to determine that it is bioequivalent to the reference medicine,
Janumet. Two medicines are bioequivalent when they produce the same levels of the active
substance in the body.

The company provided data from the published literature on sitagliptin and metformin
hydrochloride.

What are the possible side effects of Sitagliptin/Metformin Galenicum Health?

Because Sitagliptin/Metformin Galenicum Health is a generic medicine and is bioequivalent

to the reference medicine, its benefits and possible side effects are taken as being the same as
the reference medicine.

For the full list of restrictions, see the package leaflet.

Why is Sitagliptin/Metformin Galenicum Health approved?

It was concluded that, in accordance with EU requirements, Sitagliptin/Metformin Galenicum

Health has been shown to have comparable quality and to be bioequivalent to Janumet.
Therefore, the Medicines Authority decided that, as for Janumet, the benefits are greater than
its risk and recommended that it can be approved for use.

What measures are being taken to ensure the safe and effective use of
Sitagliptin/Metformin Galenicum Health?

A risk management plan has been developed to ensure that Sitagliptin/Metformin Galenicum
Health is used as safely as possible. Based on this plan, safety information has been included
in the summary of product characteristics and the package leaflet for Sitagliptin/Metformin
Galenicum Health, including the appropriate precautions to be followed by healthcare
professionals and patients.

Known side effects are continuously monitored. Furthermore new safety signals reported by
patients/healthcare professionals will be monitored/reviewed continuously as well.

Other information about Sitagliptin/Metformin Galenicum Health

The marketing authorisation for Sitagliptin/Metformin Galenicum Health was granted on 10

November 2020.

The full PAR for Sitagliptin/Metformin Galenicum Health can be found on the website of the
Medicines Authority. For more information about treatment with Sitagliptin/Metformin
Galenicum Health, read the package leaflet or contact your doctor or pharmacist.

This summary was last updated in 03-2022.

Summary PAR – Generics 3/15

 CMDh/223/2005
February 2014

Public Assessment Report

Scientific discussion

Sitagliptin/Metformin Galenicum Health 50 mg/850

mg film-coated tablets
Sitagliptin/Metformin Galenicum Health 50 mg/1000
mg film-coated tablets
Sitagliptin Hydrochloride Monohydrate
Metformin Hydrochloride

MT/H/0373/001-2/DC

Date: March 2022

This module reflects the scientific discussion for the approval of Sitagliptin/Metformin
Galenicum Health 50 mg/850 mg film-coated tablets and Sitagliptin/Metformin Galenicum
Health 50 mg/1000 mg film-coated tablets. The procedure was finalised at 17 March 2020. For
information on changes after this date please refer to the module ‘Update’.

PAR Scientific discussion 4/15

I. INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the Member States have
granted a marketing authorisation for Sitagliptin/Metformin Galenicum Health 50mg/850mg
film coated tablets and Sitagliptin/Metformin Galenicum Health 50mg/1000mg film coated
tablets from Galenicum Health S.L..

The product is indicated for:

Adult patients with type 2 diabetes mellitus:

Sitagliptin/Metformin Galenicum Health is indicated as an adjunct to diet and exercise to

improve glycaemic control in patients inadequately controlled on their maximal tolerated dose
of metformin alone or those already being treated with the combination of sitagliptin and
metformin.

Sitagliptin/Metformin Galenicum Health is indicated in combination with a sulphonylurea

(i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately
controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Sitagliptin/Metformin Galenicum Health is indicated as triple combination therapy with a

peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione)
as an adjunct to diet and exercise in patients inadequately controlled on their maximal
tolerated dose of metformin and a PPARγ agonist.

Sitagliptin/Metformin Galenicum Health is also indicated as add-on to insulin (i.e., triple

combination therapy) as an adjunct to diet and exercise to improve glycaemic control in
patients when stable dose of insulin and metformin alone do not provide adequate glycaemic
control,

A comprehensive description of the indications and posology is given in the SmPC.

This decentralised procedure concerns a generic application claiming essential similarity with
the innovator product Janumet 50 mg/850 mg and 50 mg/1000 mg film coated tablets
(EU/1/08/455) marketed by Merck Sharp & Dohme B.V., which has been authorised in the
European Union via the centralised procedure since 16 July 2008.

The concerned member state (CMS) involved in this procedure was Poland.

The marketing authorisation has been granted pursuant to Article 10(1) of Directive
2001/83/EC.

II. QUALITY ASPECTS

II.1 Introduction

Sitagliptin/Metformin Galenicum Health 50 mg/850 mg is a pink, oblong oval-shaped

film-coated tablet with a score line on one side and ‘SA’ on the other side. Each tablet
contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850
mg of metformin hydrochloride.

PAR Scientific discussion 5/15

 Sitagliptin/Metformin Galenicum Health 50 mg/1000 mg is a red to brown, oblong oval-
shaped film-coated tablets with a scoreline in between ‘S’ and ‘B’ on one side and with a
scoreline on the other side. Each tablet contains sitagliptin hydrochloride monohydrate
equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

The film-coated tablets are packed in PVC-PVDC/Aluminum blisters.

The excipients are:

Tablet core
Povidone K29/32
Microcrystalline cellulose
Crospovidone Kollidon
Sodium stearyl fumarate

Film coating
Polyvinyl alcohol E1203
Titanium dioxide E171
Macrogol 3350/PEG E1521
Talc E553b
Iron oxide yellow E172
Iron oxide red E172
Iron oxide black E172

II.2 2.2 Drug Substance

Sitagliptin Hydrochloride Monohydrate

The active substance, Sitagliptin Hydrochloride Monohydrate, is an established active

substance not described in the European Pharmacopoeia (Ph. Eur.). Sitagliptin
hydrochloride monohydrate is a white to off-white crystalline powder. It is freely soluble
in water. It is optically active and has one chiral center. The substance in slightly
hygroscopic. The manufacturer supplies the polymorphic form III of sitagliptin
hydrochloride monohydrate.

The Active Substance Master File (ASMF) procedure is used for the drug substance
Sitagliptin Hydrochloride Monohydrate. The main objective of the ASMF procedure,
commonly known as the European Drug Master File (EDMF) procedure, is to allow
valuable confidential intellectual property or ‘know‐how’ of the manufacturer of the active
substance (ASM) to be protected, while at the same time allowing the applicant or
marketing authorisation holder (MAH) to take full responsibility for the medicinal product,
the quality and quality control of the active substance. Competent Authorities/EMA thus
have access to the complete information that is necessary to evaluate the suitability of the
use of the active substance in the medicinal product.

PAR Scientific discussion 6/15

 Manufacturing process
The manufacturing process has been sufficiently described. The proposed starting
materials are acceptable. A full description of the steps is adequately provided as well as
process flow charts.

Impurities having a structural alert for genotoxicity are adequately dealt with. The reagents
used or arising in the manufacturing process of the starting material are all below
acceptable limits.

Quality control of the drug substance

The active substance specification is considered adequate to control the quality. Batch
analytical data demonstrating compliance with this specification have been provided.

Stability of drug substance

The results of a six months accelerated and a 60 month long term study are provided in
three and four batches, respectively. No significant changes in any parameters were
observed. Stability studies submitted support the proposed retest period of 48 months (at
no special storage conditions).

Metformin Hydrochloride

The active substance Metformin Hydrochloride is described in the European

Pharmacopoeia (monograph 0931). The CEP procedure is used for the drug substance
Metformin. It appears as white or almost white crystals. It is freely soluble in water. The
drug substance manufacturer supplies the polymorphic form II.

The CEP procedure is used for metformin hydrochloride. Under the official Certification
Procedure of the EDQM of the Council of Europe, manufacturers or suppliers of
substances for pharmaceutical use can apply for a certificate of suitability concerning the
control of the chemical purity and microbiological quality of their substance according to
the corresponding specific monograph, or the evaluation of reduction on Transmissible
Spongiform Encephalopathy (TSE) risk, according to the general monograph, or both. This
procedure is meant to ensure that the quality of substances is guaranteed and that these
substances comply with the Ph. Eur..

Manufacturing process
A CEP has been submitted; therefore no details on the manufacturing process have been
included.

Quality control of the drug substance

The control tests and specifications for drug substance product are adequately drawn up.
The drug substance specification comprises the tests and limits of the Ph Eur Monograph,
the CEP, and additional in-house test for microbial quality is requested to be added to the
drug substance manufacturer specification.

Stability of drug substance

The re-test period of the substance is 5 years if stored in double polyethylene bag, placed
in polyethylene drums, in line with the Certificate of Suitability.

PAR Scientific discussion 7/15

 II.3 Medicinal Product

Pharmaceutical development
The development of the product has been described, the choice of excipients is justified,
and their functions explained.

The selection of excipients during the formulation development process was based on the
manufacturing techniques to be used, desired product characteristics, components in the
reference product and previous experience with similar pharmaceutical forms.

All selected excipients are well-known, widely used in pharmaceutical industry, and
comply with relevant pharmacopoeia monographs.

Manufacturing process
The manufacturing process for Sitagliptin/Metformin Galenicum Health complies with
GMP guidelines and it is composed by common steps widely used in the Pharmaceutical
Industry. It consists of granulation, blending, tableting, coating and packaging. These are
standard steps involving no special critical stages and no intermediate-stage products.
Results of process validation have been provided for five pilot batches, manufactured at the
proposed site of manufacture and according to the proposed process. The results indicate
that the process is consistent.

Control of excipients
Specifications are set for routine test control for the excipients used in the manufacture of
the drug product Sitagliptin/Metformin Galenicum Health. The excipients comply with the
specifications of the respective pharmacopoeia monographs with the exception of the
excipient Opadry is not described in a Pharmacopeia, but complies with in-house
specifications.

Quality control of drug product

The finished product specifications are adequate to control the relevant parameters for the
dosage form. Limits in the specification have been justified and are considered appropriate
for adequate quality control of the product. Adequate descriptions and validations of the
analytical methods have been provided.

Batch analysis have been performed on five pilot batches and results show that the finished
products meet the proposed specifications.

Stability of the product

Stability studies with a total of 5 pilot batches have been conducted under long-term,
intermediate and accelerated conditions.

All batches have the same formulation (except for one colourant used in the coating – Iron
oxide yellow) and are packaged in the same container closure system proposed for
marketing.

The studies were carried according to the shelf-life specifications and used the analytical
methods for testing the finished product.

Sitagliptin/Metformin Galenicum Health 50 mg/850 mg and 50 mg/1000 mg film-coated

tablets are stable under long term and intermediate storage conditions. The tablets should

PAR Scientific discussion 8/15

 be stored below 30ºC. Considering the results obtained under the conditions studied and
the available time points the shelf life proposed is 24 months.

II.4 Discussion on chemical, pharmaceutical and biological aspects

Based on the submitted dossier, the member states consider that Sitagliptin/Metformin
Galenicum Health has a proven chemical-pharmaceutical quality. Sufficient controls have
been laid down for the active substance and finished product.

III. NON-CLINICAL ASPECTS

III.1 Ecotoxicity/environmental risk assessment (ERA)

Since Sitagliptin/Metformin Galenicum Health is intended for generic substitution, this

will not lead to an increased exposure to the environment. An environmental risk
assessment is therefore not deemed necessary.

III.2 Discussion on the non-clinical aspects

Pharmacodynamic, pharmacokinetic and toxicological properties of sitagliptin and

metformin in a combination product are well known. As sitagliptin and metformin is a
widely used, well-known active substance, the applicant has not provided additional
studies and further studies are not required. Overview based on literature review was, thus,
appropriate.

IV. CLINICAL ASPECTS

IV.1 Introduction

Sitagliptin and metformin hydrochloride are well-known active substances with an

established efficacy and tolerability. A clinical overview has been provided, which is based
on scientific literature. The overview justifies why there is no need to generate additional
clinical data. Therefore, the member states agreed that no further clinical studies are
required.

For this generic application, the MAH has submitted two bioequivalence studies, which are
discussed below.

IV.2 Pharmacokinetics

The MAH conducted two bioequivalence studies in which the pharmacokinetic profile of
the test product Sitagliptin/Metformin Galenicum Health 50 mg/850 mg & 50 mg/1000 mg
film-coated tablets is compared with the pharmacokinetic profile of the reference product
Janumet 50 mg/850 mg & 50 mg/1000 mg film-coated tablets.

Analytical/statistical methods
The analytical method has been adequately validated and is considered acceptable for
analysis of the plasma samples. The methods used in this study for the pharmacokinetic
calculations and statistical evaluation are considered acceptable.

PAR Scientific discussion 9/15

 Bioequivalence studies

Study I with 50 mg/1000 mg strength

Design
This was a single dose randomised comparative, open label, two treatments, two periods,
two sequences, crossover oral bioavailability study to establish comparative
bioequivalence of Sitagliptin/Metformin 50 mg/1000 mg film coated tablets (Test:
Galenicum Health S.L. Spain manufactured by SAG manufacturing Spain) vs Reference
Janumet (Sitagliptin/Metformin 50 mg/1000 mg film coated tablets MAH: Merck Sharpe
Dohme, UK, manufactured by Merck Sharpe and Dohme BV, the Netherlands and sourced
from Spain) in 24 healthy, adult, male human subjects (aged between 18-65 years) under
fed conditions. The objective of the study was to compare the rate and extent of absorption
of both products and to monitor the adverse events to ensure the safety and tolerability of a
single dose of Sitagliptin/Metformin 50 mg/1000 mg.

Based on the randomised schedule and following an overnight fast of at least 10 hours in
both periods each volunteer received a high fat, high calorie breakfast 30 minutes prior to
dosing.

A single oral dose of Sitagliptin/Metformin 50 mg /1000 mg with 240ml of water was

given 30 minutes after starting breakfast in period I and either one capsules of the
reference or test product in period II.

Subjects were dosed while in sitting posture and were instructed to remain seated in an
upright position for the first 4 hours following drug administration. Drinking water was not
permitted until one hour after dosing. The two periods were separated by a wash-out phase
of at least 7 days.

Blood samples were taken at specific time points pre-dose and after dosing.

Results

Table 1. Pharmacokinetic parameters (non-transformed values; arithmetic mean ±

SD, tmax median, range) for Sitagliptin (fed,n=24)

PAR Scientific discussion 10/15

 Table 2. Pharmacokinetic parameters (non-transformed values; arithmetic mean ±
SD, tmax median, range) for Metformin (fed,n=24)

Study II with 50 mg/850 mg strength

Design
This was a single dose randomised comparative, open label, two treatments, two periods,
two sequences, crossover oral bioavailability study to establish comparative
bioequivalence of Sitagliptin/Metformin 50 mg/850 mg film coated tablets (Test:
Galenicum Health S.L. Spain manufactured by SAG manufacturing Spain) vs Reference
Janumet (Sitagliptin/Metformin 50 mg/850 mg film coated tablets MAH: Merck Sharp
Dohme Ltd UK manufactured by Merck Sharpe and Dohme BV, the Netherlands sourced
from Portugal) in 25 healthy, adult, male and human subjects (aged between 18-65 years)
under fed conditions. The objective of the study was to compare the rate and extent of
absorption of both products and to monitor the adverse events to ensure the safety and
tolerability of a single dose of Sitagliptin/Metformin 50mg/850mg.

Based on the randomised schedule and following an overnight fast of at least 10 hours in
both periods each volunteer received a high fat, high calorie breakfast 30 minutes prior to
dosing.

A single oral dose of Sitagliptin/Metformin 50 mg/850 mg with 240ml of water was given
30 minutes after starting breakfast in period I and either one tablet of the reference or test
product in period II.

Subjects were dosed while in sitting posture and were instructed to remain seated in an
upright position for the first 4 hours following drug administration. Drinking water was not
permitted until one hour after dosing. The two periods were separated by a wash-out phase
of at least 7 days.

Blood samples were taken at specific time points pre-dose and after dosing.

PAR Scientific discussion 11/15

 Results

Table 3. Pharmacokinetic parameters (non-transformed values; arithmetic mean ±

SD, tmax median, range) for Sitagliptin (fed,n=25)

Table 4. Pharmacokinetic parameters (non-transformed values; arithmetic mean ±

SD, tmax median, range) for Metformin (fed,n=25)

Conclusion on bioequivalence studies:

The MMA has been assured that the bioequivalence study has been conducted in
accordance with acceptable standards of Good Clinical Practice (GCP, see Directive
2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and
2004/10/EC).

Based on the submitted bioequivalence studies Sitagliptin/Metformin Galenicum Health is

considered bioequivalent with Janumet.

The two treatments were well tolerated by the subjects (in both periods) enrolled in the
study. The adverse events were analysed and the ones related to the administration of the
test and reference product mentioned above are all included in the SmPC and there are no
new concerns arising from this study. The two products had similar safety profiles.

PAR Scientific discussion 12/15

 The 90% confidence intervals calculated for the primary parameters Cmax and AUC0-t for
both Sitagliptin and Metformin fall within the 80.00 – 125.00% acceptance range after
single dose administration under fed conditions.

IV.3 Risk Management Plan

The MAH has submitted a risk management plan, in accordance with the requirements of
Directive 2001/83/EC as amended, describing the pharmacovigilance activities and
interventions designed to identify, characterise, prevent or minimise risks relating to
Sitagliptin/Metformin Galenicum Health.

The proposed and identified summary of potential risks associated with sitagliptin and
metformin are presented below:
Important identified risk Sitagliptin
• Hypersensitivity reactions, including anaphylactic
reaction, angioedema, rash, urticaria, cutaneous vasculitis,
skin exfoliation and Stevens-Johnson syndrome
• Hypoglycemia with concomitant sulfonylurea
• Hypoglycemia with concomitant insulin
• Gastrointestinal disorders: nausea, vomiting, constipation,
diarrhea, abdominal pain, flatulence, abdominal pain
upper and related terms (dyspepsia and gastritis)
• Musculoskeletal disorders: osteoarthritis, pain in
extremity, and related terms (e.g. arthralgia, myalgia,
myopathy)
• Pancreatitis

Metformin
• Lactic acidosis
• Hepatic insufficiency
• Use of metformin before elective surgery
• Hypoglycemia following co-administration with other
antidiabetic agents
• Use in patients with renal impairment
• Concomitant use of iodinated contrast media in case of
eGFR < 60ml/min
• Use in patients with renal dysfunction with eGFR
<45ml/min
Important potential risk Sitagliptin
• Infections: Upper respiratory tract infection,
nasopharyngitis and related terms (bronchitis, acute
bronchitis, pharyngitis, sinusitis, and rhinitis)
• Neurotoxicity: tremor, ataxia, and balance disorders
• Suicidal ideation, suicide and depression
• Impaired renal function, including acute renal failure
(sometimes requiring dialysis)
• Pancreatic cancer
• Rhabdomyolysis

Metformin
• Diabetic ketoacidosis

PAR Scientific discussion 13/15

 • Decreased anti-hyperglycemic effect of metformin on
concomitant use of medicinal products with intrinsic
hyperglycemic activity
• Leucocystoclastic vasculitis
• Off-label use (especially for female patients with
polycystic ovary syndrome)
Missing information Sitagliptin
• Patients below18 years of age
• Exposure during pregnancy and lactation
• Theoretic carcinogenic potential
• Patients with severe hepatic impairment
• Cardiovascular adverse events in patients on sitagliptin or
on a combination of sitagliptin and a PPARγ agonist
• Elderly patients

Metformin
• Use in children inferior to 10 years
• Use in pregnancy and lactation

IV.4 Discussion on the clinical aspects

For this authorisation, reference is made to the clinical studies and experience with the
innovator product Janumet. No new clinical studies were conducted. The MAH
demonstrated through a bioequivalence study that the pharmacokinetic profile of the
product is similar to the pharmacokinetic profile of this reference product. Risk
management is adequately addressed. This generic medicinal product can be used instead
of the reference product.

V. USER CONSULTATION
A full user test was performed for Sitagliptin/Metformin 50 mg/1000 mg.

The overall results obtained show that 100% of the participants located and understood the
information in the leaflet and that 100% of the answers were correct. Also, the results indicate
that the leaflet is readable, that the key safety messages are understood and that the
participants can act accordingly.

From the above, one can conclude that the leaflet for Sitagliptin/Metformin Galenicum Health
50 mg/1000 mg film-coated tablets is according to the readability testing criteria established
in the current legislation.

The performed full user testing was acceptable.

A bridging report was submitted for Sitagliptin/Metformin 50 mg/850 mg. The proposed
package leaflets (Daughter PL) was bridged to the leaflet of Sitagliptin/Metformin Galenicum
Health 50mg/1000mg film-coated tablets (Parent PL). The latter was subjected to a
successful full user test which is approvable.

The applicant submitted an overview with tabulated differences between the Parent PL and
the Daughter PL, whereby the different data between the PLs were highlighted. From the
content perspective, the Daughter PL is identical to the Parent PL. This was acceptable.
PAR Scientific discussion 14/15
Data presented in the section of the report regarding design, font and layout of the Daughter
PL compared to the Parent PL is supported by the submission of the PL mock-ups for the
Daughter PL. There is no difference in the design that may affect the readability of the leaflet.

The bridging report is acceptable.

VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION
Sitagliptin/Metformin Galenicum Health 50 mg/850 mg & 50 mg/1000 mg film-coated tablets
have a proven chemical-pharmaceutical quality and are generic forms of Janumet. Janumet is
a well-known medicinal product with an established favourable efficacy and safety profile.

Bioequivalence has been shown to be in compliance with the requirements of European

guidance documents.

The MMA followed the advice of the assessors.

There was no discussion in the CMD(h). Agreement between member states was reached
during a written procedure. The concerned member states, on the basis of the data submitted,
considered that essential similarity has been demonstrated for Sitagliptin/Metformin
Galenicum Health with the reference product, and have therefore granted a marketing
authorisation. The decentralised procedure was finalised with a positive outcome on 17 March
2020.

PAR Scientific discussion 15/15