Coglapix suspension for injection for pigs
Table of contents
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
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List item
Coglapix Article-33(4) referral - Questions and answers (PDF/120.31 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMEA/V/A/109 -
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List item
Coglapix Article-33(4) referral - Annex I, II, III (PDF/147.03 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMEA/V/A/109 -
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List item
Coglapix Article-33(4) referral - Divergent position (PDF/25.62 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMEA/V/A/109
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:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies