Prontax 10 mg/ml solution for injection for cattle, sheep and pigs - referral

Current status

European Commission final decision

Overview

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs (and associated names) contains doramectin. Doramectin is a macrocyclic lactone and is closely related to ivermectin. Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.

The applicant, Pfizer Limited, submitted an application for a decentralised procedure for the above-mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended. The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden as concerned Member States, as well as Iceland and Norway.

The decentralised procedure started on 26 February 2010. Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France) and regarding the proposed withdrawal period for cattle (the Netherlands).

On 26 April 2011, the reference Member State, Ireland, referred the matter to the Committee for Medicinal Products for Veterinary Use (CVMP) pursuant to Article 33(4) of Directive 2001/82/EC.

The referral procedure started on 5 May 2011. The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur. Written explanations were provided by the applicant on 13 September 2011 and 11 January 2012.

Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna and the withdrawal period for meat and offal in cattle is set at 70 days. Therefore, CVMP adopted a positive opinion on 8 February 2012 recommending the granting of a marketing authorisation for Prontax 10 mg/ml solution for injection for cattle, sheep and 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 amendments to the summary of product characteristics, labelling and package leaflet of the reference Member State in annex III.

The final opinion was converted into a decision by the European Commission on 25 May 2012.

Opinion following an Article 33(4)1 referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names

AdoptedReference Number: EMA/281970/2012

Key facts

About this medicine

• Approved name:
  Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
• International non-proprietary name (INN) or common name:
  doramectin
• Associated names:
  Dectomax 10 mg/ml solution for injection for cattle sheep and pigs

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A-73
• 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.

Key dates and outcomes

• Opinion date:
  08/02/2012
• EC decision date:
  25/05/2012

All documents

Prontax 10 mg/ml solution - Article 33 referral- Annexes I, II, III

Opinion following an Article 33(4)1 referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names

AdoptedReference Number: EMA/281970/2012

Opinion provided by Committee for Medicinal Products for Veterinary Use

Divergent position on a CVMP opinion on an Article 33.4 referral for Prontax 10 mg/ml solution for injection for sheep, cattle and pigs (EMEA/V/A/073)

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)