Eprinex pour-on and its associated names - referral

Current status

European Commission final decision

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.

Opinion following an article 34 referral for Eprinex pour-on and its associated names

Reference Number: EMA/249804/2014

Key facts

About this medicine

• Approved name:
  Eprinex pour-on and its associated names
• International non-proprietary name (INN) or common name:
  eprinomectin
• Associated names:
  • Eprinex - Lösung zum Auftragen auf die Haut für Rinder
  • Eprinex Vet
  • Eprinex pour-on vet
  • Eprinex pour on pour bovins
  • Eprinex Pour-On for beef and dairy cattle
  • Ivomec-Eprinex Pour On voor vlees- en melkvee

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• Opinion date:
  11/02/2004
• EC decision date:
  11/08/2004

All documents

European Commission final decision

Eprinex pour-on - Article-34 - Annex I, II

Opinion following an article 34 referral for Eprinex pour-on and its associated names

Reference Number: EMA/249804/2014

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)