Eprinex pour-on and its associated names
Table of contents
Overview
Eprinex and its associated names are a pour-on solution for external use. Eprinex contains eprinomectin as an active substance at 5 mg per ml. Eprinomectin is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle including lactating cows.
Due to divergent national decisions taken by Member States concerning the marketing authorisations of Eprinex and its associated names, on 20 June 2003 Germany referred the issue to the CVMP under Article 34 of Directive 2001/82/EC, in order to resolve discrepancies regarding the withdrawal period for cattle meat and offal across the European Union.
The referral procedure started on 23 July 2003. The Committee appointed H. Hoogland as rapporteur and M. Arboix as co-rapporteur.
Written explanations were provided by the marketing authorisation holder on 25 November 2003.
Based on the available data, the CVMP considered that for Eprinex and its associated names a withdrawal period of 15 days for cattle meat and offal should be recommended. Therefore, the CVMP adopted a positive opinion on 11 February 2004 for the above-mentioned product.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
The final opinion was converted into a Decision by the European Commission on 11 August 2004.
Key facts
| Approved name |
Eprinex pour-on and its associated names
|
| International non-proprietary name (INN) or common name |
eprinomectin
|
| Associated names |
|
| Reference number |
EMEA/V/A/008
|
| 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 |
11/02/2004
|
| EC decision date |
11/08/2004
|
All documents
-
List item
Opinion following an article 34 referral for Eprinex pour-on and its associated names (PDF/73.47 KB)
First published: 11/08/2014
Last updated: 11/08/2014
EMA/249804/2014 -
List item
Eprinex pour-on - Article-34 - Annex I, II (PDF/75.49 KB)
First published: 11/08/2014
Last updated: 11/08/2014 -
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