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Community register of veterinary medicinal products


Product information

Invented name: Aftovaxpur Doe   
Auth. number : EU/2/13/153
Active substance : purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AA - Inactivated viral vaccines
Chemical substance: QI02AA04 - foot and mouth disease virus
(See WHO ATCvet Index)
Indication: Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Onset of immunity has been demonstrated 4 weeks after vaccination.
Vaccination of cattle, sheep and pigs induced the production of neutralising antibodies that persisted for at least 6 months. In cattle, the antibody levels measured were above those shown to be protective.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, 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
17/07/2013 Centralised - Authorisation EMEA/V/C/2292 (2013)4625 of 15/07/2013
09/04/2014 Centralised - 2-Monthly update EMEA/V/C/2292/II/1 (2014)2448 of 07/04/2014
22/04/2016 Centralised - 2-Monthly update EMEA/V/C/2292/II/6 (2016)2486 of 20/04/2016
13/01/2017 Centralised - Variation EMEA/V/C/2292/IB/7
Updated with Decision(2018)230 of 12/01/2018
16/01/2018 Centralised - Yearly update (2018)230 of 12/01/2018