Gemzar - referral

Current status

European Commission final decision

Overview

Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours. It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.

On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar.

The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.

This medicinal product belongs to the list of products for SPC harmonisation.

The procedure started on 21 June 2007. The Marketing Authorisation Holder provided supplementary information on 20 December 2007.

During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.

The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Gemzar.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.

A Decision was issued by the European Commission on 23 September 2008.

Opinion following an Article 30 referral for Gemzar and associated names International Non-Proprietary Name (INN): gemcitabine: Background information

Adopted Reference Number: EMEA/CHMP/512295/2008

Key facts

About this medicine

• Approved name:
  Gemzar
• International non-proprietary name (INN) or common name:
  gemcitabine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/512295/08
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  26/06/2008
• EC decision date:
  23/09/2008

All documents

Gemzar - Article 30 referral - Annex I, II, III

Adopted

Opinion following an Article 30 referral for Gemzar and associated names International Non-Proprietary Name (INN): gemcitabine: Background information

Adopted Reference Number: EMEA/CHMP/512295/2008

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.