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  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


On 6 June 1995, Denmark requested the CPMP, under Article 12 of Council Directive 75/319/EEC, to provide an Opinion “on the risks and benefit of the fluoroquinolone containing product ZAGAM” following a Rapid Alert from France dated 31 May 1995 which informed Member States of 643 case reports over 7 months, of which 80% concerned phototoxicty.

CPMP Opinions were adopted on 19 December 1995, recommending:

  • withdrawal of the Marketing Authorisation for the 100mg strength
  • variation of the Marketing Authorisation for the 200mg strength
  • changes to parts of the SPC (SPC provided in Annex 1 of the Opinion)
    - therapeutic indications
    - posology and method of administration
    - contra-indications
    - special warnings and precautions for use
    - interaction with other medicinal products and other forms of interaction
    - undesirable effects
    - pharmacodynamic properties
  • specific obligations for the MAHs as to provide the Committee with - the findings of studies investigating photomutagenicity and photocarcinogenicity by the end of 1996 - six monthly updates on efficacy and safety for at least two years from the date of the Opinion

A copy of the final Opinions for ZAGAM are provided on the Internet, together with Annexes. Translations of the Opinions and their Annexes, are also provided on the Internet in French, German, and Spanish.

The final Opinions for ZAGAM 200mg and ZAGAM 100mg were converted into Decisions by the European Commission on 6 May 1996 and 13 June 1996 respectively.

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

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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