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European Commission final decision


Nimesulide is a non-steroidal anti-inflammatory drug (NSAID).
Nimesulide containing medicinal products are currently marketed in more than 50 countries worldwide. In Europe, nimesulide is nationally authorised in 10 Member States: Austria, Belgium, Finland, France, Greece, Ireland, Italy, Luxembourg, Portugal and Spain. The first launch was in Italy in 1985. The multitude of national Marketing Authorisations granted at different points in time has lead to divergence in the approved therapeutic indications, posology, recommended duration of treatment in the European Community.

Following the granting of marketing authorisations of nimesulide containing products in Finland (January 1998), cases of hepatic adverse reactions, ranging from asymptomatic increases in liver enzymes to hepatic failure that required liver transplant, have been reported. By 13 March 2002, the Finnish National Agency for Medicines had received altogether 109 Adverse Drug Reaction reports concerning nimesulide, of these 66 were hepatic reactions, including serious reactions (e.g. hepatitis,hepatic failure, including two cases necessitating liver transplantation). Based on these serious hepatic reactions and taking into account the relatively non-serious conditions for which nimesulide is indicated for as well as the existence of numerous alternative treatments, the Marketing Authorisations of nimesulide containing medicinal products for oral administration have been suspended in Finland on 18 March 2002.

On 10 April 2002, Finland notified the CPMP and EMEA Secretariat of a referral under Article 31 of Directive 2001/83/EC as amended, requesting the CPMP to give its opinion on the risk-benefit balance of all nimesulide containing medicinal products, especially in view of the hepatic toxicity.

Furthermore, on 3 May 2002, Spain circulated a Rapid Alert about the suspension of the marketing of nimesulide containing medicinal products in their territory.

The Marketing Authorisation Holders/Applicants provided written explanations by 10 September 2002. Supplementary information was provided by 3 February 2003, 6 June 2003 and 11 July 2003. Oral explanations were given by the Marketing Authorisation Holders/Applicants on 25 June 2003.

Upon consideration of all available data, the CPMP adopted an opinion on 24 July 2003. On 21 October 2003, the European Commission returned the Opinion back to the CPMP for further consideration of its recommendation as regards to the 200 mg tablets. Therefore, the CPMP adopted a revised opinion on 17 December 2003. This revised opinion recommended the maintenance of the Marketing Authorisations for nimesulide containing medicinal products as amended and/or the granting of Marketing Authorisations in accordance with the Summaries of Product Characteristics as set out in Annex III, for all medicinal products listed in Annex I. In accordance with the CPMP assessment of the efficacy data provided by the MAHs/Applicants and with the CPMP recommendations on the maximum oral posology of 100 mg twice a day, the CPMP CPMP/1724 /04 concluded that the efficacy of the oral dosage of 200 mg twice-a-day is not supported; in consequence the Marketing Authorisations of the 200 mg tablets have been withdrawn and Marketing Authorisations for the 200 mg tablet should not be granted. In addition, the opinion contained certain conditions concerning post-marketing data and communication as set out in Annex IV.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III and the conditions of the Marketing Authorisations in Annex IV.

On the basis of the CPMP Opinion, the European Commission issued a Decision on 26 April 2004.

Notes: The information given in this document and Annexes reflect only the CPMP Opinion dated 17 December 2003. The Member States competent authorities will continue to keep the product under regular review.

Key facts

Approved name
International non-proprietary name (INN) or common name


Reference number
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

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:

  • 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

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