Leponex - referral

Current status

European Commission final decision

Overview

Clozapine is an antipsychotic drug with a broad range of antipsychotic activity. The low affinity for D2 receptor deserves clozapine a unique profile, as its use is not associated with extrapyramidal side effects. However, due to a risk of agranulocytosis, the therapeutic indication has been restricted to schizophrenic patients resistant or intolerant to other antipsychotics. Furthermore, periodic white cell counting has been required throughout treatment, being more frequent during the first 18 weeks of treatment where 88% of the cases of agranulocytosis appear.

From the registrations in Member States, different Summaries of Product Characteristics have been issued, based on national, divergent decisions. On 31 October 2000, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC¹.

The referral procedure started on 26 April 2001 in order to harmonise the Summaries of Product Characteristics (SPC) within the Member States and Norway and Iceland. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, scientific discussion within the Committee and comments from the Marketing Authorisation Holders, was of the opinion that the benefit/risk ratio of clozapine is considered to be favourable for the agreed indications. The CPMP issued a positive opinion, on 2 August 2002, recommending the harmonisation of the SPC for Leponex and associated names. The grounds for referral are appended to this report.

An overall summary of the scientific evaluation is provided together with the amended summary of product characteristics.

A Decision was issued by the European Commission on 12 November 2002.

---

¹ Corresponding to Article 11 of Directive 75/319/EEC, for referrals presented before 18 December 2001

Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Leponex and associated names International Non-Proprietary Name (INN): clozapine: Background inform...

AdoptedReference Number: EMEA/CPMP/6034/02/en/Final

Key facts

About this medicine

• Approved name:
  Leponex
• International non-proprietary name (INN) or common name:
  clozapine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/6034/02
• 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:
  02/08/2002
• EC decision date:
  12/11/2002

All documents

Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Leponex and associated names International Non-Proprietary Name (INN): clozapine: Background inform...

AdoptedReference Number: EMEA/CPMP/6034/02/en/Final

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.