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diclofenac-article-294-referral-ema-recommends-authorisation-diclofenac-sodium-spray-gel-4_cs.pdf
Preview of Czech
🔗 Source: ema.europa.eu
📊 Size: 77 KB
👤 Author: CHMP
⬇️ Downloads: 127

Summary

The European Medicines Agency (EMA) recommends authorisation of Diclofenac Sodium Spray Gel 4% in the EU, concluding that its benefits outweigh its risks. The medicine, containing the active substance diclofenac, is used to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues. The EMA review was initiated due to a disagreement among EU Member States regarding its authorisation, with concerns raised by Germany and Spain over the sufficiency of data provided by the company. However, the EMA considered the data sufficient to demonstrate the medicine's effectiveness and safety, and the European Commission issued an EU-wide legally binding decision on its marketing authorisation on 18 January 2019.

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Description

The European Medicines Agency (EMA) recommends authorisation of Diclofenac Sodium Spray Gel 4% in the EU, concluding that its benefits outweigh its risks.

Technical Information

  • File Format: PDF
  • File Size: 77 KB
  • Pages: 2
  • Language: EN
  • Author: CHMP
  • Total Downloads: 127
  • Last Updated: 14 hours ago

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