Bifril, Teoula, Zofepril, Zopranol

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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.

Key facts

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

Status
European Commission final decision
Opinion date
27/07/2000
EC decision date
29/11/2000

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP 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 are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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