Gripovac 3 (inactivated influenza-A virus / swine) – Conditions or restrictions regarding supply and use - QI09AA03

Updated on site: 21-Sep-2017

Medication name: Gripovac 3
ATC: QI09AA03
Substance: inactivated influenza-A virus / swine
Manufacturer: Merial S.A.S.; 

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

Name and address of the manufacturer of the biological active substance

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

Germany

Name and address of the manufacturer(s) responsible for batch release

IDT Biologika GmbH

Am Pharmapark

06861 Dessau-Rosslau

Germany

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

Veterinary medicinal product subject to prescription

C.STATEMENT OF THE MRLs

The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.

The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

Comments