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The Certificate has been invalidated, invalidated date is : 2023-09-22

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Austrian Medicines and Medical Devices Agency

CERTIFICATE NUMBER: 482462-100791849

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of AUSTRIA confirms the following:

The manufacturer: Baxalta US Inc.

Site address:

25212 West Il Route 120, Round Lake, IL, 60073-9610, United States

OMS Organisation Id. / OMS Location Id.: ORG-100011981 / LOC-100073446

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-09-16 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.4 Small volume liquids

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.1  Blood products
           1.3.1.8  Other: aseptic filling, pasteurization and packaging of Flexbumin(en)

1.5 Packaging

1.5.2 Secondary packaging

Clarifying remarks (for public users):

Baxalta US Inc. Biologics Facility; limited to the manufacturing and packaging of Flexbumin products

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