DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

CERTIFICATE OF ANALYSIS

Product trade name: CINRYZE 500 UI

Batch Number Finished Product: C4V018
Batch Number (labelled): C4V018AG
Filling Size: 500 IU
Date of Manufacture: 09 2020
Number of Final
Containers for Release: 7757 pieces
Expiry Date: 08 2022
Storage Temperature: +2°C to +25°C; do not freeze
Destination country/countries: ROMANIA, LITHUANIA

PLASMA CERTIFICATE
This is to certify that each single plasma donation used for the manufacture of the product has been tested
for HBs-antigen, HIV-1/2-antibody and HCV-antibody by Immunoassay. Only plasma found non-reactive for
HBs-antigen, HIV-1/2-antibody and HCV-antibody has been used for the manufacture of the product.
In addition, each plasma pool derived from plasma donations tested as described above, has been tested
for HBs-antigen and HIV-1/2-antibody by Immunoassay and for viral nucleic acids of HAV, HBV, HCV, HIV-
1/2 and B19V by NAT. Only plasma pools found non-reactive for HBs-antigen, HIV-1/2-antibody, HAV
RNA, HBV DNA, HCV RNA, HIV-1/2 RNA and containing not more than 104 I.U. B19V DNA/ml are used for
the manufacture of the product.

The following plasma pools were used for the manufacture of the product:
0206181_10, 0306181_10, 2005181_10, 2405181_10
(see enclosed Official Control Authority Batch Release certificates)

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, AT
Handelsgericht Wien, FN: 491521 a, UID: ATU74323029
UniCredit Bank Austria, Kto.-Nr.: 10023 475 402, BLZ:12000, IBAN: AT261200010023475402, Swift Code: BKAUATWW
C4-Standard-V01.04 page 1 of 3
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C
Dept. BAMA
Possingergasse 38, AT-1160 Wien
Dieter Pullirsch; email: dieter.pullirsch@ages.at
Phone:+43(0)5 0555 36361 ; Fax: +43(0)5 0555 36309

EU/EEA CERTIFICATE OF APPROVAL FOR PLASMA POOLS FOR USE IN THE MANUFACTURE OF
MEDICINAL PRODUCTS
Examined in the context of Official Control Authority Batch Release of medicinal products derived from human blood or plasma in application of
Article 114 of Directive 2001/83/EC and amended by Directive 2004/27/EC.

Name and address of manufacturer of plasma pools (site of Qualified Person

signing summary protocol unless otherwise indicated):
Baxter Spa
Via della Chimica 5
IT-02010 S. Rufina, Cittaducale Rieti

Code numbers of Date of Volume Country PMF reference

sample No: plasma pools: manufacture of pools (l): of origin: (+certification):

20007252 0106181_10 01.06.2018 2419,933 US EMEA/H/PMF/000003/2004

20007253 0106181_20 01.06.2018 2419,933 US EMEA/H/PMF/000003/2004
20007254 0206181_10 02.06.2018 2428,177 US EMEA/H/PMF/000003/2004
20007255 0206181_20 02.06.2018 2428,177 US EMEA/H/PMF/000003/2004
20007271 0305181_10 03.05.2018 2447,076 US EMEA/H/PMF/000003/2004
20007270 0305181_20 03.05.2018 2447,076 US EMEA/H/PMF/000003/2004
20007258 0306181_10 03.06.2018 2407,715 US EMEA/H/PMF/000003/2004
20007259 0306181_20 03.06.2018 2407,715 US EMEA/H/PMF/000003/2004
20007256 0706181_10 07.06.2018 2432,092 US EMEA/H/PMF/000003/2004
20007257 0706181_20 07.06.2018 2432,092 US EMEA/H/PMF/000003/2004

These plasma pools have been examined using documented procedures, which form part of a quality system which is in accordance with the EN ISO/IEC 17025
standard. This examination is based on the current EU OCABR guideline 'Official Control Authority Protocol for Approval of Plasma Pools': review of the plasma pool
protocol and the following testing: The samples of these plasma pools (received: 22.01.2020) have been tested and found negative for the following virological
markers: anti HIV 1+2 (EIA), HBsAg (EIA) and HCV RNA (NAT).
These plasma pools are in compliance with the approved specifications laid down in the relevant European Pharmacopoeia monograph(s) and are approved.

Signed:

Name and Function of Signatory: Dr. Dieter Pullirsch

Date of Issue: 28.01.2020
Release Certificate Number: ZAT-200324

BASG - Austrian Federal Office for Safety in Health Care

Traisengasse 5 l 1200 Vienna l AUSTRIA l www.basg.gv.at
DVR: 2112611 Page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C
Dept. BAMA
Possingergasse 38, AT-1160 Wien
Dieter Pullirsch; email: dieter.pullirsch@ages.at
Phone:+43(0)5 0555 36361 ; Fax: +43(0)5 0555 36309

EU/EEA CERTIFICATE OF APPROVAL FOR PLASMA POOLS FOR USE IN THE MANUFACTURE OF
MEDICINAL PRODUCTS
Examined in the context of Official Control Authority Batch Release of medicinal products derived from human blood or plasma in application of
Article 114 of Directive 2001/83/EC and amended by Directive 2004/27/EC.

Name and address of manufacturer of plasma pools (site of Qualified Person

signing summary protocol unless otherwise indicated):
Baxter Spa
Via della Chimica 5
IT-02010 S. Rufina, Cittaducale Rieti

Code numbers of Date of Volume Country PMF reference

sample No: plasma pools: manufacture of pools (l): of origin: (+certification):

20007232 1605181_10 16.05.2018 2443,195 US EMEA/H/PMF/000003/2004

20007233 1605181_20 16.05.2018 2443,195 US EMEA/H/PMF/000003/2004
20007234 1705181_10 17.05.2018 2428,683 US EMEA/H/PMF/000003/2004
20007235 1705181_20 17.05.2018 2428,683 US EMEA/H/PMF/000003/2004
20007236 1805181_10 18.05.2018 2422,931 US EMEA/H/PMF/000003/2004
20007237 1805181_20 18.05.2018 2422,931 US EMEA/H/PMF/000003/2004
20007238 2005181_10 20.05.2018 2426,636 US EMEA/H/PMF/000003/2004
20007239 2005181_20 20.05.2018 2426,636 US EMEA/H/PMF/000003/2004
20007240 2105181_10 21.05.2018 2435,001 US EMEA/H/PMF/000003/2004
20007241 2105181_20 21.05.2018 2435,001 US EMEA/H/PMF/000003/2004

These plasma pools have been examined using documented procedures, which form part of a quality system which is in accordance with the EN ISO/IEC 17025
standard. This examination is based on the current EU OCABR guideline 'Official Control Authority Protocol for Approval of Plasma Pools': review of the plasma pool
protocol and the following testing: The samples of these plasma pools (received: 22.01.2020) have been tested and found negative for the following virological
markers: anti HIV 1+2 (EIA), HBsAg (EIA) and HCV RNA (NAT).
These plasma pools are in compliance with the approved specifications laid down in the relevant European Pharmacopoeia monograph(s) and are approved.

Signed:

Name and Function of Signatory: Dr. Dieter Pullirsch

Date of Issue: 28.01.2020
Release Certificate Number: ZAT-200327

BASG - Austrian Federal Office for Safety in Health Care

Traisengasse 5 l 1200 Vienna l AUSTRIA l www.basg.gv.at
DVR: 2112611 Page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C
Dept. BAMA
Possingergasse 38, AT-1160 Wien
Dieter Pullirsch; email: dieter.pullirsch@ages.at
Phone:+43(0)5 0555 36361 ; Fax: +43(0)5 0555 36309

EU/EEA CERTIFICATE OF APPROVAL FOR PLASMA POOLS FOR USE IN THE MANUFACTURE OF
MEDICINAL PRODUCTS
Examined in the context of Official Control Authority Batch Release of medicinal products derived from human blood or plasma in application of
Article 114 of Directive 2001/83/EC and amended by Directive 2004/27/EC.

Name and address of manufacturer of plasma pools (site of Qualified Person

signing summary protocol unless otherwise indicated):
Baxter Spa
Via della Chimica 5
IT-02010 S. Rufina, Cittaducale Rieti

Code numbers of Date of Volume Country PMF reference

sample No: plasma pools: manufacture of pools (l): of origin: (+certification):

20007244 2205181_10 22.05.2018 2415,698 US EMEA/H/PMF/000003/2004

20007245 2205181_20 22.05.2018 2415,698 US EMEA/H/PMF/000003/2004
20007248 2305181_10 23.05.2018 2453,361 US EMEA/H/PMF/000003/2004
20007249 2305181_20 23.05.2018 2453,361 US EMEA/H/PMF/000003/2004
20007250 2405181_10 24.05.2018 2433,223 US EMEA/H/PMF/000003/2004
20007251 2405181_20 24.05.2018 2433,223 US EMEA/H/PMF/000003/2004
20007274 2904181_10 29.04.2018 2456,074 US EMEA/H/PMF/000003/2004
20007275 2904181_20 29.04.2018 2456,074 US EMEA/H/PMF/000003/2004

These plasma pools have been examined using documented procedures, which form part of a quality system which is in accordance with the EN ISO/IEC 17025
standard. This examination is based on the current EU OCABR guideline 'Official Control Authority Protocol for Approval of Plasma Pools': review of the plasma pool
protocol and the following testing: The samples of these plasma pools (received: 22.01.2020) have been tested and found negative for the following virological
markers: anti HIV 1+2 (EIA), HBsAg (EIA) and HCV RNA (NAT).
These plasma pools are in compliance with the approved specifications laid down in the relevant European Pharmacopoeia monograph(s) and are approved.

Signed:

Name and Function of Signatory: Dr. Dieter Pullirsch

Date of Issue: 28.01.2020
Release Certificate Number: ZAT-200328

BASG - Austrian Federal Office for Safety in Health Care

Traisengasse 5 l 1200 Vienna l AUSTRIA l www.basg.gv.at
DVR: 2112611 Page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

BATCH NUMBER: C4V018

CONTROL TESTS ON FINISHED PRODUCT

Test Method Specification Result
1. C1-Inhibitor Activity Chromogenic Assay 80 – 125 IU/ml 85 IU/ml
2. Specific C1-inhibitor Calculation 4 – 9 IU/mg 6 IU/mg
activity
3. Total protein Kjeldahl Method 10 – 20 g/L 13 g/L
4. Solubility (at 20°C to Dissolution Time Dissolution time: < 5 min; 1 min
25°C) completely soluble
Clarity (after Visual Inspection of the Appearance of solution: clear clear
reconstitution) Solution
Color (after Visual Inspection of Solution Appearance of solution: colorless
dissolving) < BL1
Stability Visual Inspection of Solution Appearance of solution: clear; clear, no clotting
(appearance after no clotting
dissolving 3 hours at
room temperature)
5. Water content Karl Fischer Method < 0.04 g/g 0.01 g/g
(Residual moisture)
6. Osmolality Measurement of the 200 - 400 mOsmol/kg 297 mOsmol/kg
Depression of Freezing Point
7. Sodium ICP-OES 80 – 120 mmol/L 103 mmol/L
8. Sucrose HPLC-RI 40 - 80 mmol/L 58 mmol/L
9. Citrate Enzymatic UV-testing 5 – 15 mmol/L 10 mmol/L
10. Valine HPLC-UV 11 – 20 mmol/L 18 mmol/L
11. Alanine HPLC-UV 9 – 17 mmol/L 14 mmol/L
12. Threonine HPLC-UV 30 – 45 mmol/L 40 mmol/L
13. pH-Value (directly Potentiometry 6.8 – 7.2 7.0
measured in
solution)
14. Sterility (Ph. Eur.) Membran Filtration sterile sterile
15. Bacterial Endotoxins Chromogenic Kinetic Method ≤ 5.0 EU/ml <0.5 EU/ml
16. Appearance Visual inspection of solution Essentially free from visible complies
(after reconstitution) particles
17. Sub-visible particles Particle Count Test (Light ≥ 10 µm: ≤ 6000 particles/vial 14 particles/vial
Obscuration) ≥ 25µm: ≤ 600 particles/vial 0 particles/vial
18. Purity SE-HPLC C1-inhibitor Monomer (%): 83 %
≥ 65 %
Low molecular weight species 16 %
(incl. α1ACT (%): ≤ 26 %
High molecular weights 1 %
species (%):≥ 0 % (report
results)

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, AT
Handelsgericht Wien, FN: 491521 a, UID: ATU74323029
UniCredit Bank Austria, Kto.-Nr.: 10023 475 402, BLZ:12000, IBAN: AT261200010023475402, Swift Code: BKAUATWW
C4-Standard-V01.04 page 2 of 3
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

BATCH NUMBER: C4V018

I hereby certify that all the manufacturing stages of this batch of finished product have been carried out in full
compliance with the GMP requirements of the EU and with the requirements of the Marketing Authorisation(s) of
the destination country/countries.

SIGNATURE

Performed by: Approved by:

QA Disposition Qualified Person

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, AT
Handelsgericht Wien, FN: 491521 a, UID: ATU74323029
UniCredit Bank Austria, Kto.-Nr.: 10023 475 402, BLZ:12000, IBAN: AT261200010023475402, Swift Code: BKAUATWW
C4-Standard-V01.04 page 3 of 3
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

MARKETING INFORMATION FORM

Notification of the intention to market a batch of an immunological medicinal product, which has a marketing
authorisation, or medicinal product derived from human blood or plasma, which has a marketing authorisation, in the
following EC/EEA member state Romania

TAKEDA PHARMACEUTICALS SRL

Addressee: Piata Presei Libere, No. 3-5, 15th floor, City
Gate Building, South Tower, Right Wing
District 1, Bucharest, Romania

Trade Name: Cinryze 500 IU/I.E.

Presentation: Multivial 2 vials
Batch number(s) appearing on the market package: C4V018AG
Batch number(s) appearing on the OMCL release
C4V018
certificate:

Number of presentations to be marketed in the 480

member state:

Number of containers (vials) to be marketed in the 960

member state:

Number of containers relased: 7757 pieces

Market authorisation number: EU/1/11/688/001
Name and address of marketing authorisation Shire Services BVBA
holder: Rue Montoyer 47
B - 1000 Brussels, Belgium
Date of start of period of validity: 23-SEP-2020
Expiry date in the member state where the batch is 31-AUG-2022
to be marketed:

Intended date of marketing: 05 2021

OMCL performing batch release: BASG - Austrian Federal Office for Safety in
Health Care; Vienna, Austria
Official batch release certificate number: ZAT-204209

I hereby declare that:

-this batch is in compliance with the above marketing authorisation and the relevant
European Pharmacopoeia monographs;
-this batch is the batch referred to in the accompanying batch release certificate.
A copy of the batch release certificate is attached.

Signature of qualified person:

Name of qualified person:

Date of issue:

MIF-C4-Romania-V01.00 page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

MARKETING INFORMATION FORM

Notification of the intention to market a batch of an immunological medicinal product, which has a marketing
authorisation, or medicinal product derived from human blood or plasma, which has a marketing authorisation,
in the following EC/EEA member state Lithuania

State Medicines Control Agency

Addressee:
15 Rygos str.
LT - 05245 VILNIUS

Trade Name: Cinryze 500 IU/I.E.

Batch number(s) appearing on the market
C4V018AG
package:
Batch number(s) appearing on the OMCL
C4V018
release certificate:
Number of containers relased: 7757 pieces
Market authorisation number: EU/1/11/688/001
Name and address of marketing authorisation Shire Services BVBA
holder: Rue Montoyer 47
B - 1000 Brussels, Belgium
Date of start of period of validity: 23-SEP-2020
Expiry date in the member state where the 31-AUG-2022
batch is to be marketed:

BASG - Austrian Federal Office for Safety in

OMCL performing batch release:
Health Care; Vienna, Austria
Official batch release certificate number: ZAT-204209

I hereby declare that:

- this batch is in compliance with the above marketing authorisation and the relevant
European Pharmacopoeia monographs;
- this batch is the batch referred to in the accompanying batch release certificate.
A copy of the batch release certificate is attached.

Signature of qualified person:

Name of qualified person:
Date of issue:

Will be filled out by Country QA after QP signature:

Intendet date of marketing:
Numbers of containers to be marketed in the
member state:
Name, date and signature:

MIF-C4-Baltics-V01.00 page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

CERTIFICATE OF ANALYSIS FOR SOLVENT

WATER FOR INJECTION 5 ml / 10 ml / 20 ml

used as diluent for

CINRYZE 500 UI

Batch No.: C4V018

Batch No (labelled): C4V018AG

Manufacturer: Siegfried Hameln GmbH, 31789 Hameln, Germany

Batch No.: H000219

Filling Size: 5 ml
Expiry Date: 09 2025

Test results see enclosed addendum.

Baxter
Aktiengesellschaft

Qualified Person

WFI-Standard-V01.01 page 1 of 1
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

Siegfried

Certificate of Analysis
To whom it may concern
Printout date
11/12/2020

Page
1 of 2

Material: 7906600 Wfl, STER, 5ml, EP/USP/JP, UNLBLD

Customer Material: 3500044

Techn. quality agreement: current Version

Batch: H000219
Batch Siegfried: 2042HMF010

Manufacturing date: 10/12/2020 Exp. date: 09/2025

Test specification: 7906000 Version: 12/03/2018

Specification
Lower Upper
Characteristics Unit Result Limit Limit

Analysis on finished produots

Appearance " complies clear solution
Clarity and Opalescence (Ph.Eur./USP)
Appearance complies colourless solution
Colour (Ph.Eur./USP)
Appearance (JP) complies clear and
colourless
solution, odourless
Foreign Insoluble Matter (JP) - complies complies
Extractable volume ml 5.3 5.0
(Ph.Eur./USP/JP)
Acidity or Alkalinity - complies complies
(Ph.Eur.)
Oxidisable substances (Ph.Eur./USP) - complies complies
Potassium Permanganate- - complies complies
reducing substances (JP)
Ammonium (Ph.Eur.) - complies max. 0.6 ppm
Calcium and Magnesium (Ph.Eur.) - complies complies

Our Companies terms and conditions are applicable and to be read on our website www.siegfried.ch
Siegfried Hameln GmbH, Langes Feld 13, 31789 Hameln, Geschäftsführer: Dr. Sabine Brand, Torsten Förster,
Amtsgericht Hannover HRB 100015, USt.-ID Nr. DE 811165138

www.siegfried.ch
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

Siegfried

Page
2 of 2

Material: 7906600 Wfl, STER, 5ml, EP/USP/JP, UNLBLD

Customer Material: 3500044

Techn. quality agreement: current Version

Batch: H000219
Batch Siegfried: 2042HMFQ10

Manufacturing date: 10/12/2020 Exp. date: 09/2025

Specification
Lower Upper
Characteristics Unit Result Limit Limit

Sulfates (Ph.Eur.) - complies complies

Chlorides (Ph.Eur.) - complies max. 0.5 ppm
Nitrates (Ph.Eur.) - complies max. 0.2 ppm
Aluminium (Ph.Eur./AAS) - complies max. 50 ppb
Residue on Evaporation (Ph.Eur.) % < 0.001 0.004
Conductivity (Ph.Eur.) uS/cm 2 25
Conductivity (USP/JP) |iS/cm 2 25
Insoluble Particulate Matter /cont. 1 6000
(sub-visible particles)
(>/= 10 pm/s.v.)
(Ph.Eur./USP/JP)
Insoluble Particulate Matter /cont. 0 600
(sub-visible particles)
(>/= 25 pim/s.v.)
(Ph.Eur./USP/JP)
Sterility (Ph.Eur./USP/JP) - complies complies
Endotoxins (Ph.Eur./USP/JP) EU/ml <0.12 0.24

Siegfried Hameln GmbH (formerly hameln pharmaceuticals gmbh until 01/2018)

Sieqfrb ?
Siegfrisdü- . ^mbH
Postfacg 10 Cb 63, Langes Feld 13
?m£Vi
iiaabet]
Hameln, 11/12/2020
Dr. Oläl hagon
Qualifie' erson

End

Our Companies terms and conditions are applicable and to be read on our website www.siegfried.ch
Siegfried Hameln GmbH, Langes Feld 13,31789 Hameln, Geschäftsführer: Dr. Sabine Brand, Torsten Förster,
Amtsgericht Hannover HRB 100015, USt.-ID Nr. DE 811165138
www.siegfried.ch
DocuSign Envelope ID: 0D2D1047-974F-48C5-BBBE-6BAFAFAAB51C

Dept. BAMA
Possingergasse 38, AT-1160 Wien
Dipl.Ing. (FH) Christoph Kefeder; e-mail: christoph.kefeder@ages.at
Phone: +43(0)5 0555 36331; Fax: +43(0)5 0555 36309
To: Baxter AG, AT

EU/EEA OFFICIAL CONTROL AUTHORITY BATCH RELEASE CERTIFICATE - Finished Product

Examined under Article 114 of Directives 2001/83/EC as amended by Directive 2004/27/EC (Medicinal
Products derived from Human Blood or Plasma) and in accordance with the Administrative Procedure
for Official Control Authority Batch Release.

Trade name: Cinryze 500IU

International non-propriety name / Ph. Eur. name / Human C1 inhibitor
common name:
Batch numbers appearing on package and other C4V018
identification numbers associated with this batch:
Type of container: Vials of moulded glass, type I
Total number of containers in this batch: 7757
Nominal dose per container: 500 IU
Date of start of period of validity: 23.09.2020
Date of expiry: 31.08.2022
Marketing authorisation number (member state / EU) EU/1/11/688/001 (Germany)
issued by:
Name and address of manufacturer (site of Qualified Takeda Manufacturing Austria AG
Person signing summary protocol unless otherwise Industriestraße 67
indicated): AT-1221 Wien
Name and address of marketing authorisation holder: Shire Services BVBA
Rue Montoyer 47
BE-1000 Brussels

This batch has been examined using documented procedures which form part of a quality system which is
in accordance with the EN/ISO 17025 standard.
This examination is based on the relevant EU OCABR guideline for this product.
All constituent plasma pools have been tested by an OMCL for virological markers.

This batch is in compliance with the approved specifications laid down in the relevant
European Pharmacopoeia monographs and the above marketing authorisation and is released.

Signed:

Name and Function of Signatory: Dipl.Ing. (FH) Christoph Kefeder

Date of Issue: 19.10.2020
Release Certificate Number: ZAT-204209
20112924

BASG - Austrian Federal Office for Safety in Health Care Page 1 of 1

Traisengasse 5 l 1200 Vienna l AUSTRIA l www.basg.gv.at
DVR: 2112611
Certificate Of Completion
Envelope Id: 0D2D1047974F48C5BBBE6BAFAFAAB51C Status: Completed
Subject: C4V018AG_CoA.pdf
Department: QA Disposition
Document Type: CoA
Source Envelope:
Document Pages: 12 Signatures: 5 Envelope Originator:
Certificate Pages: 2 Initials: 0 Said Durakovic
AutoNav: Enabled 40 Landsdowne Street
EnvelopeId Stamping: Enabled Cambridge, MA 02139
Time Zone: (UTC+01:00) Amsterdam, Berlin, Bern, Rome, Stockholm, Vienna said.durakovic@takeda.com
IP Address: 165.225.200.197

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