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


The review of the liver-related safety of 'systemic formulations' of medicines containing nimesulide has been completed. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines still outweigh their risks, and that there is a need to restrict their use to ensure that the risk of patients developing liver problems is kept to a minimum. 'Systemic formulations' are medicines that are given as a treatment throughout the body, such as tablets, solutions and suppositories. The European Commission endorsed the CHMP opinion with a further restriction to limit the use of these medicines to 'second-line' (used when at least one other medicine has failed).

The European Commission issued a decision on 16 October 2009.

Key facts

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


Associated names
  • Aulin
  • Nimed
Reference number
Article 107 procedures (prior to July 2012)

This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i.

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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