Gripovac 3

Withdrawn

This medicine's authorisation has been withdrawn

inactivated influenza-A virus / swine

Overview

The marketing authorisation for Gripovac 3 has been withdrawn at the request of the marketing authorisation holder.

Gripovac 3 : EPAR - Summary for the public

Product information

Gripovac 3 : EPAR - Product Information

Gripovac 3 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Gripovac 3
• 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) 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

Changes since initial authorisation of medicine

Gripovac 3 : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Gripovac 3 : EPAR - Procedural steps taken before authorisation

Gripovac 3 : EPAR - Scientific Discussion

Committee for medicinal products for veterinary use summary of opinion: Gripovac 3: International Non-proprietary Names (INN): Inactivated vaccine against swine influenza in pigs

AdoptedReference Number: EMEA/CVMP/661084/2009