Suifertil 4-mg/ml oral solution for pigs and associated names

Current status
European Commission final decision

Overview

Suifertil 4-mg/ml oral solution for pigs contains altrenogest as active ingredient and is intended for use in pigs for the synchronisation of oestrous in sexually mature gilts.

The applicant, aniMedica GmbH, submitted an application for a decentralised procedure for Suifertil 4-mg/ml oral solution for pigs and associated names. This is a generic application according to Article 13(1) of Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml. France is the reference Member State and Austria, Germany, Hungary, the Netherlands, Poland, Romania, Spain and the United Kingdom are concerned Member States.

The decentralised procedure started on 7 October 2011. Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.

On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual Recognition and Decentralised Procedures (Veterinary) (CMDv) was started on 17 December 2012. Day 60 of the CMDv procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product, the procedure was referred to the Committee for Medicinal Products for Veterinary Use (CVMP).

On 1 March 2013, the reference Member State, France, notified the European Medicines Agency that the CMDv had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.

The referral procedure started on 6 March 2013. The Committee appointed Dr C. Ibrahim as rapporteur and Dr M. Holzhauser-Alberti as corapporteur. Written explanations were provided by the applicant on 21 May 2013.

Having considered all the data submitted in writing, the CVMP concluded that there is no product-specific concern identified for the Suifertil 4-mg/ml oral solution for pigs that is different from the other, already authorised, altrenogest-containing veterinary medicinal products. Therefore, the Committee adopted a positive opinion by consensus on 18 July 2013 recommending the granting of a marketing authorisation for Suifertil 4-mg/ml oral solution for pigs and associated names.

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

The opinion was converted into a decision by the European Commission on 2 October 2013.

Key facts

Approved name
Suifertil 4-mg/ml oral solution for pigs and associated names
International non-proprietary name (INN) or common name
altrenogest
Associated names
Synchroplan
Current status
European Commission final decision
Reference number
EMEA/V/A/094
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.

Opinion date
18/07/2013
EC decision date
02/10/2013

All documents

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 characteristicslabelling 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)

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