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Current status:
European Commission final decision


The European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of 'oral formulations' of medicines containing norfloxacin for the treatment of complicated pyelonephritis. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of these medicines do not outweigh their risks for this type of infection, and that this indication should be removed from the marketing authorisations for these medicines throughout Europe. The review was carried out under an 'Article 31' referral1.

The use of other formulations of norfloxacin, such as injections, and its use for other diseases, were unaffected by the CHMP's review.

1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.

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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