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

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.

Key facts

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
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.

Status
European Commission final decision
Opinion date
08/02/2012
EC decision date
25/05/2012

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating