Gripovac 3

RSS

Withdrawn

This medicine's authorisation has been withdrawn

inactivated influenza-A virus
MedicineVeterinaryWithdrawn

Swedish is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

The marketing authorisation for Gripovac 3 has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information:R/0005
04/12/2014

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Product details

Name of medicine
Gripovac 3
Active substance
inactivated influenza-A virus
International non-proprietary name (INN) or common name
inactivated influenza-A virus
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) code
QI09AA03

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.

Onset of immunity: 7 days after primary vaccination.

Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.

Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.

Authorisation details

EMA product number
EMEA/V/C/000157
Marketing authorisation holder
Merial S.A.S. 

Merial S.A.S.
29 avenue Tony Garnier
69007 Lyon
France

Marketing authorisation issued
14/01/2010
Revision
1

Assessment history

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