Bifril, Teoula, Zofepril, Zopranol - referral

Current status

European Commission final decision

Overview

Bifril/Teoula/Zofepril/Zopranol is supplied in film-coated tablet containing 4.5, 15, 30 or 60 mg of the active substance zofenopril, which is an angiotensin converting enzyme inhibitor. The indication when first authorised in all Member States following a Mutual Recognition Procedure was the treatment of mild to moderate essential hypertension.

In October 1999, Menarini International Operations Luxembourg SA submitted applications for a Type II variation in the Mutual Recognition procedure, with the United Kingdom as Reference Member State, for Bifril/Teoula/Zofepril/Zopranol. The scope of the variation was to extend the indication to include the treatment of acute myocardial infarction and to update the SPC. The Mutual Recognition Variation procedure started on 29 November 1999. The Concerned Member States were Belgium, Denmark, Germany, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, The Netherlands, Austria, Portugal, and Sweden. The Concerned Member State, Germany, not agreeing with the Reference Member State's Final Variation Assessment Report referred the reasons for disagreement to the EMEA on 5 June 2000, with a request to initiate an arbitration procedure in order to clarify the matter.

The objections raised by Germany were related to grant an indication in patients with an acute myocardial infarction of any site and in patients who received thrombolytic therapy. The arbitration procedure started on 30 June 2000.

The CPMP, having considered the points of disagreement, the proposed Summary of Product Characteristics by the (Co-)Rapporteurs and the written comments provided by the Marketing Authorisation Holders, was of the opinion by consensus that the objections raised by Germany should not prevent the approval of the variation applied for.

The CPMP therefore adopted a positive opinion on 27 July 2000 CPMP recommending the granting of the variation of the Marketing Authorisation for Bifril/Teoula/Zofepril/Zopranol, and the amendment of the Summary of Product Characteristics.

An overall summary of the scientific evaluation is provided, together with the amended SPC.

A Decision was issued by the European Commission on 29 November 2000.

Opinion following a referral for arbitration according to Article 7(5) of Commission Regulation (EC) No 541/95 as amended, for Bifril/Teoula/Zofepril/Zopranol International Non-Proprietary Name (INN): zofenopril: Backgro...

AdoptedReference Number: CPMP/4362/00

Key facts

About this medicine

• Approved name:
  Bifril, Teoula, Zofepril, Zopranol
• International non-proprietary name (INN) or common name:
  zofenopril

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/4362/00
• Type:
  Article 6(12) referrals (prior to January 2010)

  This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.

Key dates and outcomes

• CHMP opinion date:
  27/07/2000
• EC decision date:
  29/11/2000

All documents

Opinion following a referral for arbitration according to Article 7(5) of Commission Regulation (EC) No 541/95 as amended, for Bifril/Teoula/Zofepril/Zopranol International Non-Proprietary Name (INN): zofenopril: Backgro...

AdoptedReference Number: CPMP/4362/00

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
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• 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. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (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)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.