Diclofenac epolamine 50 mg tablets

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


On 21 July 2016, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine diclofenac epolamine (50 mg tablets). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of this product do not outweigh its risks, and the marketing authorisation cannot be granted in the United Kingdom (UK) or in the following Member States of the EU: Czech Republic, France and Slovakia.

Key facts

Approved name
Diclofenac epolamine 50 mg tablets
International non-proprietary name (INN) or common name
Reference number
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
Opinion date
EC decision date

All documents

Document description

  • 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:


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