• Procedure started
  • Under evaluation
  • 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

About this medicine
Approved name
International non-proprietary name (INN) or common name
About this procedure
Current status
European Commission final decision
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.

Key dates and outcomes
CHMP opinion date

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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