CattleMarker IBR Inactivated
Table of contents
Overview
On 17 March 2016, 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 CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated). The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Key facts
Approved name |
CattleMarker IBR Inactivated
|
International non-proprietary name (INN) or common name |
Infectious bovine rhinotracheitis vaccine (inactivated) |
Reference number |
EMEA/V/A/115
|
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 |
17/03/2016
|
EC decision date |
10/06/2016
|
All documents
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List item
CattleMarker IBR Inactivated Article-33(4) referral - Questions and answers (PDF/77.19 KB)
First published: 19/07/2016
Last updated: 19/07/2016
EMA/290855/2016 -
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List item
CattleMarker IBR Inactivated Article-33(4) referral - Annex I, II, III, IV (PDF/101.84 KB)
First published: 19/07/2016
Last updated: 19/07/2016
EMEA/V/A/115 -
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List item
CattleMarker IBR Inactivated Article-33(4) referral - Divergent position (PDF/37.43 KB)
First published: 19/07/2016
Last updated: 19/07/2016
EMEA/V/A/115
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