Doramectin - referral

Current status

European Commission final decision

Overview

Doramectin is an antiparasitic agent. It is a macrocyclic lactone closely related to ivermectin. Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.

On 22 March 2012, the Netherlands presented a referral notification under Article 35 of Directive 2011/82/EC to the Agency, regarding all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food-producing species. The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion regarding the adequacy and consumer safety of the withdrawal periods for all injectable and pour-on veterinary medicinal products containing doramectin and whether there is a risk to the environment and the need for risk-mitigation measures following use of the products concerned.

The referral started on 12 April 2012. The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Kolar as corapporteur. Written explanations were provided by the applicants and marketing authorisation holders on 17 September 2012, 3 January 2013 and 9 May 2013.

Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods, inclusion of warning sentences concerning the use in dairy animals and environmental risk-mitigation measures. Therefore, the Committee adopted a positive opinion on 12 June 2013, recommending variations to the terms of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food-producing species.

The list of product names concerned is given in annex I. The scientific conclusions are provided in annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in annex III.

The final opinion was converted into a decision by the European Commission on 6 September 2013.

Opinion following an Article-35 referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food-producing species

Reference Number: EMA/372468/2013

Key facts

About this medicine

• Approved name:
  Doramectin
• International non-proprietary name (INN) or common name:
  doramectin
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/081
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  12/06/2013
• EC decision date:
  06/09/2013

All documents

European Commission final decision

Doramectin - Article-35 referral - Annexes I, II, III

Opinion following an Article-35 referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food-producing species

Reference Number: EMA/372468/2013

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)