Lederfoline - referral

Current status

European Commission final decision

Overview

Calcium folinate is the calcium salt of 5-formyl tetrahydrofolic acid. It is an active metabolite of folinic acid and an essential coenzyme for nucleic acid synthesis in cytotoxic therapy.

National Marketing Authorisations for Lederfoline and associated names had been granted in all 15 Member States, based on national decisions. Some of the Marketing Authorisations (e.g. all presentations in Italy, Denmark, Finland, France, Sweden and The Netherlands) have been withdrawn upon Marketing Authorisation Holders' requests.

France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, (corresponding to Article 11 of Directive 75/319/EEC, as amended, to referrals presented before 18 December 2001) in order to harmonise the nationally authorised summaries of product characteristics of the medicinal product Lederfoline and associated names, (calcium folinate, solution for injection). In their notification, the French agency noted that there were divergences relating to various sections of the SPCs, particularly with respect to “indications”, “posology” and “contra-indications”.

At its 23-25 April 2002 meeting, the CPMP adopted a list of questions and initiated the procedure.

During the meeting on 18-19 March 2003, the CPMP, 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 was acceptable and that the SPC should be amended. A positive opinion was therefore adopted by the CPMP on 19 March 2003.

The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 30 June 2003.

Summary information on a referral opinion following an arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Lederfoline and associated names (see Annex I) International Non-Proprietary Name (INN): calci...

AdoptedReference Number: EMEA/CPMP/3736/03

Key facts

About this medicine

• Approved name:
  Lederfoline
• International non-proprietary name (INN) or common name:
  calcium folinate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/3736/03
• 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:
  20/03/2003
• EC decision date:
  30/06/2003

All documents

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

Adopted

Summary information on a referral opinion following an arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Lederfoline and associated names (see Annex I) International Non-Proprietary Name (INN): calci...

AdoptedReference Number: EMEA/CPMP/3736/03

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.