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The Certificate has been withdrawn, withdrawn date is : 2024-07-04

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2023/080

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Belgium confirms the following:

The manufacturer: Corixa Corp.

Site address:

325 North Bridge Street, Marietta, PA, 17547-1134, United States

OMS Organisation Id. / OMS Location Id.: ORG-100001945 / LOC-100007504

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:Article 114 of the royal decree of 14 December 2006 related to medicinal products for human and veterinary use.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-14 , 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)
1.1.1.2 Lyophilisates

1.3 Biological medicinal products (list of product types)

1.3.1 Biological medicinal products (list of product types)
1.3.1.2 Immunological products

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.4  Biological

Withdrawal comments in English: adaptation company name

Withdrawal comments in National Language: adaptation nom de la firme

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