BTVPUR Alsap 8
adjuvanted bluetongue virus vaccine
Table of contents
Overview
The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
BTVPUR Alsap 8
|
| Agency product number |
EMEA/V/C/000146
|
| Active substance |
bluetongue virus serotype 8 antigen
|
| International non-proprietary name (INN) or common name |
adjuvanted bluetongue virus vaccine
|
| Species |
|
| Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI02AA08
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merial
|
| Revision |
5
|
| Date of issue of marketing authorisation valid throughout the European Union |
17/03/2009
|
| Contact address |
29 Avenue Tony Garnier |
Product information
13/03/2014 BTVPUR Alsap 8 - EMEA/V/C/000146 - R/0010
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
-
Immunologicals for ovidae
-
Immunologicals for bovidae
Therapeutic indication
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.