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Community register of veterinary medicinal products


Product information

Invented name: BTVPUR AlSap 2-4   
Auth. number : EU/2/10/108
Active substance : 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)

Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.

The duration of immunity is 1 year after primary vaccination course.
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
9/11/2010 Centralised - Authorisation EMEA/V/C/139 (2010)7831 of 5/11/2010
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
15/04/2014 Centralised - Variation EMEA/V/C/139/S/4 (2014)2647 of 11/04/2014
4/08/2015 Centralised - Renewal EMEA/V/C/139/R/6 (2015)5573 of 31/07/2015