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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|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, F-69007 Lyon, France
|EPAR and active 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.
|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|