Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: ProteqFlu-Te   
Auth. number : EU/2/03/038
INN : Not available
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI05 - Immunologicals for equidae
Pharmacological subgroup: QI05A - Horse
Chemical subgroup: QI05AI - Live viral and inactivated bacterial vaccines
Chemical substance: QI05AI01 - Equine influenza virus + clostridium
(See WHO ATCvet Index)
Indication: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical
signs and virus excretion after infection, and against tetanus to prevent mortality.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme:
-5 months after the primary vaccination course;
-after the primary vaccination course and the booster injection 5 months later: 1 year with regard
to equine influenza and 2 years with regard to tetanus.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, F-69007 Lyon, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/03/2003 Centralised - Authorisation EMEA/V/C/74 (2003)769 of 06/03/2003
04/06/2003 Centralised - Variation EMEA/V/C/74/I/1
23/10/2003 Centralised - Variation EMEA/V/C/74/I/2, 3 (2003)3939 of 17/10/2003
07/01/2005 Centralised - Variation EMEA/V/C/74/II/4 (2005)14 of 05/01/2005
16/02/2006 Centralised - Variation EMEA/V/C/74/X/5 (2006)497 of 13/02/2006
31/10/2007 Centralised - Variation EMEA/V/C/74/II/6 (2007)5370 of 29/10/2007
15/01/2008 Centralised - Renewal EMEA/V/C/74/R/9 (2008)158 of 11/01/2008
25/01/2008 Centralised - Variation EMEA/V/C/74/II/8 (2008)333 of 22/01/2008
29/04/2008 Centralised - Variation EMEA/V/C/74/X/7 (2008)1760 of 25/04/2008
16/02/2010 Centralised - Variation EMEA/V/C/74/II/10
20/05/2011 Centralised - Variation EMEA/V/C/74/II/11 (2011)3599 of 18/05/2011
08/03/2013 Centralised - Renewal EMEA/V/C/74/R/15 (2013)1414 of 06/03/2013
15/07/2014 Centralised - Variation EMEA/V/C/74/II/17 (2014)5050 of 11/07/2014