BTVPUR Alsap 8
Withdrawn
This medicine's authorisation has been withdrawn
adjuvanted bluetongue virus vaccine
MedicineVeterinaryWithdrawn
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- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.
Product information
Latest procedure affecting product information:R/0010
13/03/2014
Product details
- Name of medicine
- BTVPUR Alsap 8
- Active substance
- bluetongue virus serotype 8 antigen
- International non-proprietary name (INN) or common name
- adjuvanted bluetongue virus vaccine
- Species
- Sheep
- Cattle
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA08
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.
News on BTVPUR Alsap 8
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