Denagard 45%
Table of contents
Current status:
European Commission final decision
Overview
On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU).
Key facts
Approved name |
Denagard 45%
|
International non-proprietary name (INN) or common name |
Tiamulin hydrogen fumarate |
Associated names |
|
Reference number |
EMEA/V/A/114
|
Type |
Article 34
Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States. |
Status |
European Commission final decision
|
Opinion date |
12/04/2017
|
EC decision date |
14/07/2017
|
All documents
-
List item
Denagard 45% Article-34 referral - Questions and answers on Denagard 45% and its associated names (PDF/74.22 KB)
First published: 11/08/2017
Last updated: 11/08/2017
EMA/275123/2017 -
-
List item
Denagard 45% Article-34 referral - Annex I,II,III (PDF/262.8 KB)
First published: 11/08/2017
Last updated: 11/08/2017
EMEA/V/A/114 -
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