Gripovac 3

inactivated influenza-A virus / swine

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Gripovac 3?

Gripovac 3 is a vaccine that contains three different strains of swine influenza-A virus which have been inactivated (killed). Gripovac 3 is a suspension for injection.

What is Gripovac 3 used for?

Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.

Gripovac 3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing, so that the sows' milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.

How does Gripovac 3 work?

Gripovac 3 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Gripovac 3 contains small amounts of a modified and then killed form of the swine influenza virus that causes lesions and illness. The vaccine also contains ‘adjuvants’ to stimulate a better response. When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. This protects the pigs against the disease.

How has Gripovac 3 been studied?

The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.

How has Gripovac 3 been studied?

The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.

What benefit has Gripovac 3 shown during the studies?

Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza-A virus.

What is the risk associated with Gripovac 3?

A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within two days. Sometimes, a slight increase in the rectal temperature might occur after vaccination.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, only a minor injection-site reaction is expected.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

Zero days.

Why has Gripovac 3 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination 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 and recommended that Gripovac 3 be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Gripovac 3

The European Commission granted a marketing authorisation valid throughout the European Union for Gripovac 3 to Merial on 14 January 2010. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Gripovac 3 : EPAR - Summary for the public BG = bălgarski 2010-01-25  
Gripovac 3 : EPAR - Summary for the public ES = español 2010-01-25  
Gripovac 3 : EPAR - Summary for the public CS = čeština 2010-01-25  
Gripovac 3 : EPAR - Summary for the public DA = dansk 2010-01-25  
Gripovac 3 : EPAR - Summary for the public DE = Deutsch 2010-01-25  
Gripovac 3 : EPAR - Summary for the public ET = eesti keel 2010-01-25  
Gripovac 3 : EPAR - Summary for the public EL = elliniká 2010-01-25  
Gripovac 3 : EPAR - Summary for the public EN = English 2010-01-25  
Gripovac 3 : EPAR - Summary for the public FR = français 2010-01-25  
Gripovac 3 : EPAR - Summary for the public IT = italiano 2010-01-25  
Gripovac 3 : EPAR - Summary for the public LV = latviešu valoda 2010-01-25  
Gripovac 3 : EPAR - Summary for the public LT = lietuvių kalba 2010-01-25  
Gripovac 3 : EPAR - Summary for the public HU = magyar 2010-01-25  
Gripovac 3 : EPAR - Summary for the public MT = Malti 2010-01-25  
Gripovac 3 : EPAR - Summary for the public NL = Nederlands 2010-01-25  
Gripovac 3 : EPAR - Summary for the public PL = polski 2010-01-25  
Gripovac 3 : EPAR - Summary for the public PT = português 2010-01-25  
Gripovac 3 : EPAR - Summary for the public RO = română 2010-01-25  
Gripovac 3 : EPAR - Summary for the public SK = slovenčina 2010-01-25  
Gripovac 3 : EPAR - Summary for the public SL = slovenščina 2010-01-25  
Gripovac 3 : EPAR - Summary for the public FI = suomi 2010-01-25  
Gripovac 3 : EPAR - Summary for the public SV = svenska 2010-01-25  

This EPAR was last updated on 22/12/2014 .

Authorisation details

Product details

Product details for Gripovac 3
NameGripovac 3
Agency product numberEMEA/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) codeQI09AA03

Publication details

Publication details for Gripovac 3
Marketing-authorisation holder

Merial S.A.S.
 

Revision1
Date of issue of marketing authorisation valid throughout the European Union14/01/2010

Contact address:

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

Product information

Product information

04/12/2014  Gripovac 3 -EMEA/V/C/000157 -R/0005

Name Language First published Last updated
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22
Gripovac 3 : EPAR - Product Information SV = svenska 2010-01-25 2014-12-22

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.


Name Language First published Last updated
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  
Gripovac 3 : EPAR - All Authorised presentations SV = svenska 2010-01-25  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Gripovac 3 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-12-22  

Initial marketing-authorisation documents