BTVPUR Alsap 8

Withdrawn

This medicine's authorisation has been withdrawn

adjuvanted bluetongue virus vaccine

Overview

The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.

BTVPUR Alsap 8 : EPAR - Summary for the public

Reference Number: EMA/116345/2009

Product information

BTVPUR Alsap 8 : EPAR - Product Information

BTVPUR Alsap 8 : EPAR - All Authorised presentations

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.

Authorisation details

• EMA product number:
  EMEA/V/C/000146
• Marketing authorisation holder:
  Merial

  29 Avenue Tony Garnier; 69007 Lyon; France

• Marketing authorisation issued:
  17/03/2009
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

BTVPUR Alsap 8 : EPAR - Procedural steps taken and scientific information after authorisation

BTVPUR Alsap 8-V-C-146-S-08 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/471401/2012

Initial marketing authorisation documents

BTVPUR Alsap 8 : EPAR - Scientific Discussion

BTVPUR Alsap 8 : EPAR - Procedural steps taken before authorisation

Committee for medicinal products for veterinary use summary of opinion: BTVPUR Alsap 8: International Non-proprietary Names (INN): inactivated bluetongue virus Serotype 8

Adopted Reference Number: EMEA/CVMP/685571/2008