Milaxyn Plus - referral

Current status

European Commission final decision

Overview

Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus (and associated names) are veterinary medicinal products as tablets for dogs containing 50 mg praziquantel, 50 mg pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg of febantel. Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative. Pyrantel embonate (pamoate) is a tetrahydropyrimidine derivative. Febantel is a probenzimidazole. These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.

Due to the divergent national decisions taken by Member States regarding the indications and use in pups less than 9 weeks of age and dogs weighing less than 2.5 kg concerning the authorisations of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names, on 22 July 2011 France referred the issue to the Committee for Medicinal Products for Veterinary Use (CVMP) under Article 34(1) of Directive 2001/82/EC, in order to resolve the abovementioned divergences.

The referral procedure started on 14 September 2011. The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur. Written explanations were provided by the marketing-authorisation holder on 2 December 2011.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus and associated names (authorised via mutual-recognition-procedure number IE/V/0272-0275/001/MR) remains positive subject to variation of the marketing authorisations in accordance with the recommended changes to the product information. Therefore, the CVMP adopted a positive opinion on 7 March 2012, recommending variations to the terms of the marketing authorisations for Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus (and associated names) (authorised via mutual-recognition-procedure number IE/V/0272-0275/001/MR) and the maintenance of the marketing authorisations for Prazitel Plus, Exitel Plus and Cazitel Plus (and associated names) (authorised via mutual-recognition-procedure number IE/V/0241-0243/001/MR).

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

The final opinion was converted into a decision by the European Commission on 18 June 2012.

Opinion following an Article 34 referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names

Reference Number: EMA/289985/2012

Key facts

About this medicine

• Approved name:
  Milaxyn Plus
• International non-proprietary name (INN) or common name:
  • praziquantel
  • pyrantel
  • febantel
• Associated names:
  • Strantel Plus
  • Prazical Plus
  • Voxical Plus
  • Exitel Plus
  • Cazitel Plus and Prazitel Plus

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/076
• 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:
  07/03/2012
• EC decision date:
  18/06/2012

All documents

Milaxyn Plus: Article 34 referral - Annex I, II, III

Opinion following an Article 34 referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names

Reference Number: EMA/289985/2012

Opinion provided by Committee for Medicinal Products for Veterinary Use

Divergent position on a CVMP opinion on an Article 34 referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names

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)