Diclofenac Sodium Spray Gel 4%

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


On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.

Key facts

Approved name
Diclofenac Sodium Spray Gel 4%
International non-proprietary name (INN) or common name

diclofenac sodium

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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