Ingelvac PCV FLEX

Withdrawn

This medicine's authorisation has been withdrawn

porcine circovirus vaccine (inactivated)

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

Ingelvac PCV FLEX : EPAR - Summary for the public

Reference Number: EMA/186905/2017

Product information

Ingelvac PCV FLEX : EPAR - Product Information

Ingelvac PCV FLEX : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ingelvac PCV FLEX
• Active substance:
  porcine circovirus type 2 ORF2 protein
• International non-proprietary name (INN) or common name:
  porcine circovirus vaccine (inactivated)
• Species:
  Pigs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI09AA07

Pharmacotherapeutic group

Immunologicals for suidae

Therapeutic indication

For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2)

Authorisation details

• EMA product number:
  EMEA/V/C/004645
• Marketing authorisation holder:
  Boehringer Ingelheim Vetmedica GmbH

  Binger Strasse 173; 55216 Ingelheim am Rhein; Germany

• Opinion adopted:
  16/03/2017
• Marketing authorisation issued:
  24/05/2017
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Ingelvac PCV FLEX : EPAR - Public assessment report

Reference Number: EMA/186905/2017

CVMP summary of positive opinion for Ingelvac PCV FLEX

Adopted Reference Number: EMA/CVMP/132641/2017