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The Certificate has been withdrawn, withdrawn date is : 2024-03-05

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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 482997-100920232

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of AUSTRIA confirms the following:

The manufacturer: Sandoz GmbH

Site address:

Schaftenau Plant, Biochemiestraße 10, Unterlangkampfen, Langkampfen, Tirol, 6336, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000546 / LOC-100001678

Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Investigational product) NIP-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-09-20 , 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
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.2 Non-sterile products

1.2.2 Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.2  Batch Certification (list of product types)
           1.3.2.5  Biotechnology products
           1.3.2.8  Other: Monoklonale Antikörper / Monoclonal antibodies(en)

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 Chemical/Physical

Manufacture of active substance. Names of substances subject to inspection:

[900000005572]The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:The complete list of APIs that are subject to quality control testing is available to the Austrian Federal Office for Safety in Health Care (BASG/AGES)

3.6 Quality Control Testing

3.6.1 Physical / Chemical testing

Clarifying remarks (for public users):

Sandoz GmbH - Betriebsstätte, Manufacturing Site: Technical Research & Development Schaftenau (TRD Schaftenau); ad 1.1, 1.2 und 1.3 eingeschränkt auf klinische Prüfpräparate / regarding 1.1, 1.2 und 1.3 restricted to investigational medicinal products

Withdrawal comments in English: withdraw of authorisation according to para 66b AMG

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