Fortekor - referral

Current status

European Commission final decision

Overview

Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.

Benazeprilat is a highly potent and selective inhibitor of angiotensin-converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5-mg, 5-mg and 20-mg flavoured tablets and 5-mg and 20-mg film-coated tablets intended for use in dogs and cats. The product is intended for the treatment of heart failure in dogs and/or the treatment of chronic kidney disease in cats and dogs, and the approved indications and target species varied between the Member States.

Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the Committee for Medicinal Products for Veterinary Use (CVMP) under Article 34(1) of Directive 2001/82/EC.

The referral procedure started on 11 November 2009. The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.

In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.

Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011. Oral explanations were given on 4 May 2011. Further to the marketing-authorisation holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs. An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.

Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information. The Committee adopted a positive opinion by majority on 10 November 2011.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.

The final opinion was converted into a Decision by the European Commission on 6 February 2012.

Opinion following an Article 341 referral for Fortekor and associated names: Background information

AdoptedReference Number: EMA/965903/2011

Key facts

About this medicine

• Approved name:
  Fortekor
• International non-proprietary name (INN) or common name:
  benazepril hydrochloride

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/055
• 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:
  10/11/2011
• EC decision date:
  06/02/2012

All documents

Fortekor: Article 34 referral - Annex I, II, III

Adopted

Opinion following an Article 341 referral for Fortekor and associated names: Background information

AdoptedReference Number: EMA/965903/2011

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)