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

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.

Summary information on a referral opinion following an arbitration pursant to Article 29 of Council Directive 2001/83/EC for Fluconazol Tiefenbacher 50mg, 100mg 150 mg, 200mg capsules, hard International Non-Proprietery ...

Adopted Reference Number: CPMP/6236/04

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  24/07/2003
• EC decision date:
  01/12/2003

All documents

Fluconazol Tiefenbacher 50mg, 100mg 150 mg, 200mg capsules, hard - Article 29 referral - Annex I, II (English) and Annex III (All languages)

Adopted

Summary information on a referral opinion following an arbitration pursant to Article 29 of Council Directive 2001/83/EC for Fluconazol Tiefenbacher 50mg, 100mg 150 mg, 200mg capsules, hard International Non-Proprietery ...

Adopted Reference Number: CPMP/6236/04

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.