Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Fluconazole is a triazole antifungal agent used against a variety of fungal infections. Fluconazole acts by inhibition of the formation of ergosterol, an important component of the fungal cell membrane.

A marketing authorisation for Fluconazol Tiefenbacher was granted in Sweden to Alfred E. Tiefenbacher GmbH & Co Germany, on 4 October 2002. An application for mutual recognition of Fluconazol Tiefenbacher was submitted to Germany and the Mutual Recognition Procedure started on 24.10.2002.

On 23 January 2003 Germany presented to the EMEA a referral under Article 29 of Council Directive 2001/83/EC, as amended. The referral by Germany related to the teratogenic and QT-prolongation potential of the active ingredient, the triazole antifungal fluconazole addressed in sections 4.3 and 4.6 of the SPC.

The referral procedure started 23 January 2003.

During its July 2003 meeting, the CPMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted provided amendment to the summary of product characteristics. A positive opinion was therefore adopted on 24 July 2003.

The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II, together with the amended Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 1 December 2003.

Key facts

Approved name
Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard
International non-proprietary name (INN) or common name

Fluconazole

Reference number
CPMP/6236/04
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
24/07/2003
EC decision date
01/12/2003

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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