Canazole - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU. The marketing authorisation in Ireland should also be suspended.

What is Canazole?

Canazole is a cream that contains the active substance clotrimazole (1%). It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.

The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles. It works by preventing the formation of ergosterol, which is an important part of fungal cell walls. Without ergosterol, the fungus is killed or prevented from spreading.

Canazole is a generic medicine based on a 'reference medicine', Canesten, which is authorised in the United Kingdom.

Why was Canazole reviewed?

Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000. The company which recently marketed this product wanted the authorisation to be recognised in the United Kingdom (the 'concerned Member State'). However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.

The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated. The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State. In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.

The European Commission issued a Decision on 22 September 2011.

Questions and answers on the referral for Canazole (clotrimazole cream 1%)

Adopted Reference Number: EMA/206825/2011 Summary:

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.

Key facts

About this medicine

• Approved name:
  Canazole
• International non-proprietary name (INN) or common name:
  clotrimazole
• Associated names:
  Canesten

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1286
• 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:
  17/03/2011
• EC decision date:
  22/09/2011

All documents

Canazole - Article 29 referral - Assessment report

Reference Number: EMEA/H/A-29/1286

Canazole - Article 29 referral - Annex I

Reference Number: EMEA/H/A-29/1286

Canazole - Article 29 referral - Annex II

Reference Number: EMEA/H/A-29/1286

Canazole - Article 29 referral - Annex III

Reference Number: EMEA/H/A-29/1286

Questions and answers on the referral for Canazole (clotrimazole cream 1%)

Adopted Reference Number: EMA/206825/2011 Summary:

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.

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.