- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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
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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.
European Commission final decision
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Questions and answers on the referral for Prokanazol capsules containing itraconazole 100 mg (PDF/77.93 KB)Adopted
First published: 16/07/2009
Last updated: 16/07/2009
Prokanazol - Article 29 referral - Annex I, II, III (PDF/87.61 KB)Adopted
First published: 06/08/2009
Last updated: 06/08/2009
- 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