Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: BTVPUR AlSap 2-4   
Auth. number : EU/2/10/108
INN : Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AA - Inactivated viral vaccines
Chemical substance: QI02AA08 - Bluetongue virus
(See WHO ATCvet Index)
Indication: Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
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 continues to be 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
09/11/2010 Centralised - Authorisation EMEA/V/C/139 (2010)7831 of 05/11/2010
12/01/2012 Centralised - Annual reassessment EMEA/V/C/139/S/1
27/02/2013 Centralised - Annual reassessment EMEA/V/C/139/S/3 (2013)1185 of 25/02/2013