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Rabigen SAG2 (live attenuated rabies virus, SAG2 strain) – Conditions or restrictions regarding supply and use - QI07AA02

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

VIRBAC SA

L.I.D. 1ère Avenue - 2065 m 06516 Carros,

France

Manufacturing Authorisation issued on December 22nd 1997 by the Ministère de la solidarité, de la santé et de la protection sociale – Direction de la Pharmacie et du médicament – République Française.

Name and address of the manufacturer responsible for batch release

VIRBAC SA

L.I.D. 1ère Avenue - 2065 m 06516 Carros,

France

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription.

The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use the veterinary medicinal product must consult the relevant Member State’s Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.

Restricted to duly designated competent administrative authorities.

C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT

Not applicable.

D.STATEMENT OF THE MRLs

Not applicable.

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