Prokanazol - 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 Prokanazol. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Prokanazol do not outweigh its risks, and that the marketing authorisation granted in the Czech Republic cannot be recognised in other Member States of the EU. The marketing authorisation in the Czech Republic should also be suspended.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 14 July 2009.

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Prokanazol?

Prokanazol is an antifungal medicine. It is used to treat adults with infections caused by fungi. It can be used in local infections, such as infections of the vulva or vagina (female sexual organs) or infections of the skin or the eye. It can also be used in systemic infections (infections that affect the whole body), including tropical infections. Prokanazol can be used against a range of fungi and yeasts, including Candida, Aspergillus and Cryptococcus.

The active substance in Prokanazol, itraconazole, is an antifungal substance that belongs to the group '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. Prokanazol is a generic medicine that is based on a reference medicine authorised in the Czech Republic (Sporanox 100 mg capsules). Prokanazol is also marketed under the name Prokanaz.

Why was Prokanazol reviewed?

The company PRO.MED.CS Praha a. s. submitted Prokanazol for mutual recognition on the basis of the initial authorisation granted by the Czech Republic on 30 July 2003. The company wanted the authorisation to be recognised in Latvia, Lithuania, Poland, Slovakia and Slovenia (the 'concerned Member States'). However, because the concerned Member States were not able to reach an agreement, the Czech medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.

The grounds for the referral were that one of the concerned Member States, Poland, did not agree that enough evidence had been presented to show that Prokanazol was 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence to the reference medicinal product has not been shown. The CHMP therefore concluded that the benefits of Prokanazol do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.

In addition, the Committee has also recommended that the marketing authorisation for Prokanazol in the Czech Republic should be suspended.

Questions and answers on the referral for Prokanazol capsules containing itraconazole 100 mg

Adopted Reference Number: EMEA/CHMP/499991/2009

Key facts

About this medicine

• Approved name:
  Prokanazol
• International non-proprietary name (INN) or common name:
  itraconazole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/454809/2009
• 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:
  23/04/2009
• EC decision date:
  14/07/2009

All documents

Prokanazol - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Prokanazol capsules containing itraconazole 100 mg

Adopted Reference Number: EMEA/CHMP/499991/2009

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.