Coglapix suspension for injection for pigs

Current status:
European Commission final decision

Overview

On 3 June 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Coglapix suspension for injection for pigs. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Coglapix outweigh its risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU (see below). The product information for Coglapix in Hungary should also be amended.

Key facts

Approved name
Coglapix suspension for injection for pigs
International non-proprietary name (INN) or common name
inactivated porcine actinobacillosis vaccine
Reference number
EMEA/V/A/109
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.

Status
European Commission final decision
Opinion date
03/06/2015
EC decision date
28/08/2015

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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