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Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2024-05-14

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National Veterinary Medicines Agency

CERTIFICATE NUMBER: 19/227956

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of France confirms the following:

The manufacturer: Laboratoire Icare

Site address:

Biopole Clermont Limagne, Rue Emile Duclaux, Saint Beauzire, 63360, France

OMS Organisation Id. / OMS Location Id.: ORG-100033884 / LOC-100053417

Has been inspected under the national inspection programme in accordance with Art. 88 of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2018-12-19 , 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

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.2 Microbiological: non-sterility

Clarifying remarks (for public users):

This certificate is valid until December 17th 2023

Withdrawal comments in English: this certificate is replaced by the new certificate 24/353399

Withdrawal comments in National Language: ce certificat est remplacé par le nouveau certificat 24/353399

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