Gripovac 3

RSS

inactivated influenza-A virus / swine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Gripovac 3 has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 04/09/2018

Authorisation details

Product details
Name
Gripovac 3
Agency product number
EMEA/V/C/000157
Active substance
  • inactivated influenza-A virus
  • swine
International non-proprietary name (INN) or common name
inactivated influenza-A virus / swine
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AA03
Publication details
Marketing-authorisation holder
Merial S.A.S. 
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
13/01/2010
Contact address
Merial S.A.S.
29 avenue Tony Garnier
69007 Lyon
France

Product information

03/12/2014 Gripovac 3 - EMEA/V/C/000157 - R/0005

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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