Diflucan - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Diflucan. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU).

What is Diflucan?

Diflucan is an antifungal medicine that belongs to the triazoles group. It contains the active substance fluconazole.

Diflucan works by preventing the formation of ergosterol, which is an important part of fungal cell walls. Without ergosterol, the fungus dies or is prevented from spreading. Diflucan is used to treat various fungal infections, including candidiasis (thrush) and fungus in the nails.

Diflucan is also available in the EU under other trade names: Fluconazole, Fungustatin, Fungata, Triflucan.

The company that markets these medicines is Pfizer.

Why was Diflucan reviewed?

Diflucan is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Diflucan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 18 February 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diflucan in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Diflucan can be used for the following conditions: mucosal and invasive candidiasis, genital candidiasis (trush), crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis. The Committee harmonised the wording on the use of the medicine for these conditions, specifying when it is to be used for treatment and prophylaxis (prevention) and introducing restrictions for certain indications. The use in children was further clarified.

4.2 Posology and method of administration

The CHMP harmonised the dosing recommendations for the various indications to be in line with international guidelines.

4.3 Contraindications

The CHMP agreed that Diflucan should not be used in patients who are hypersensitive (allergic) to the active substance, to related azole substances, or to any of other ingredient of the medicine.

Medicines known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin should also not be given to patients receiving Diflucan. Terfenadine must also not be used in patients receiving Diflucan at multiple doses of 400 mg per day or higher.

Other changes

Other sections harmonised by the CHMP include sections on special warnings, side effects, interactions, pharmacological properties and quality.

The European Commission issued a decision on 2 September 2011.

Questions and answers on Diflucan and associated names (fluconazole, 50, 100, 150 and 200 mg capsules, oral solution 5 mg/ml, powder for oral suspension 10 mg/ml or 40 mg/ml, solution for infusion 2 mg/ml)

Adopted Reference Number: EMA/CHMP/478970/2011 Summary:

The European Medicines Agency has completed a review of Diflucan. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU).

Key facts

About this medicine

• Approved name:
  Diflucan
• International non-proprietary name (INN) or common name:
  fluconazole
• Associated names:
  • Fluconazole
  • Fungustatin
  • Fungata
  • Triflucan

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1156
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  23/06/2011
• EC decision date:
  02/09/2011

All documents

Diflucan - Article 30 referral - Annex II

Diflucan - Article 30 referral - Annex III

Diflucan - Article 30 referral - Assessment Report

Adopted Reference Number: EMEA/H/A-30/1156

Diflucan - Article 30 referral - Annex I

Adopted

Questions and answers on Diflucan and associated names (fluconazole, 50, 100, 150 and 200 mg capsules, oral solution 5 mg/ml, powder for oral suspension 10 mg/ml or 40 mg/ml, solution for infusion 2 mg/ml)

Adopted Reference Number: EMA/CHMP/478970/2011 Summary:

The European Medicines Agency has completed a review of Diflucan. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU).

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.