Aftovaxpur DOE

Withdrawn

This medicine's authorisation has been withdrawn

inactivated vaccine against foot-and-mouth disease

Overview

Aftovaxpur DOE has been withdrawn at the request of the marketing authorisation holder.

Aftovaxpur DOE : EPAR - Summary for the public

Reference Number: EMA/301053/2013

Product information

Aftovaxpur DOE : EPAR - Product Information

Aftovaxpur DOE : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Aftovaxpur DOE
• Active substance:
  Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.
• International non-proprietary name (INN) or common name:
  inactivated vaccine against foot-and-mouth disease
• Species:
  • Pigs
  • Cattle
  • Sheep
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AA04

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.

Authorisation details

• EMA product number:
  EMEA/V/C/002292
• Marketing authorisation holder:
  Boehringer Ingelheim Vetmedica GmbH

  55216 Ingelheim am Rhein; Germany

• Marketing authorisation issued:
  15/07/2013
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Aftovaxpur DOE : EPAR - Procedural steps taken and scientific information after authorisation

Reference Number: EMA/573851/2014

Aftovaxpur DOE-V-C-2292-II-0009 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/807571/2018

Aftovaxpur DOE-V-C-2292-II-0001 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/182548/2014

CVMP post-authorisation summary of positive opinion for Aftovaxpur DOE

Adopted Reference Number: EMA/CVMP/109591/2014

Initial marketing authorisation documents

Aftovaxpur DOE : EPAR - Public assessment report

Adopted Reference Number: EMA/389517/2013

CVMP summary of positive opinion for Aftovaxpur DOE

Adopted Reference Number: EMA/CVMP/257822/2013