Suvaxyn PCV

Withdrawn

This medicine's authorisation has been withdrawn

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

Overview

The marketing authorisation for Suvaxyn PCV has been withdrawn at the request of the marketing authorisation holder.

Suvaxyn PCV : EPAR - Summary for the public

Reference Number: EMA/388793/2009

Product information

Suvaxyn PCV : EPAR - Product Information

Suvaxyn PCV : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Suvaxyn PCV
• Active substance:
  porcine circovirus recombinant virus (CPCV) 1-2, inactivated
• International non-proprietary name (INN) or common name:
  adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
• Species:
  Pigs (piglets)
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI09AA07

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.

Authorisation details

• EMA product number:
  EMEA/V/C/000149
• Marketing authorisation holder:
  Zoetis Belgium SA

  Rue Laid Burniat 1; 1348 Louvain-la-Neuve; Belgium

• Marketing authorisation issued:
  24/07/2009
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Suvaxyn PCV : EPAR - Procedural steps taken and scientific information after authorisation

CVMP post-authorisation summary of negative opinion for Suvaxyn PCV

Adopted Reference Number: EMA/CVMP/686504/2013

CVMP post-authorisation summary of negative opinion for Suvaxyn PCV

Adopted Reference Number: EMA/CVMP/404045/2013

Initial marketing authorisation documents

Suvaxyn PCV : EPAR - Scientific Discussion

Reference Number: EMEA/352270/2009

Suvaxyn PCV : EPAR - Procedural steps taken before authorisation

Committee for medicinal products for veterinary use summary of opinion: Suvaxyn PCV: International Non-proprietary Names (INN): Gamithromycin

Adopted Reference Number: EMEA/CVMP/257211/2009