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
|
Current status |
European Commission final decision
|
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. |
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
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)