Anorectics - referral

Current status

European Commission final decision

Overview

On 17 May 1995, Germany requested the CPMP, under Article 12 of Council Directive 75/319/EEC, to provide an Opinion “on the risks and benefit of chemically defined, centrally acting anorectics and on their authorisation status” due to concerns about the risk of patients using anorectic agents, in the treatment of obesity, to develop primary pulmonary hypertension. The substances involved in the procedure were classified into three types, Type I-III as listed above.

According to the CPMP Opinions given on 15 February 1996, the SPC's of medicinal products containing these substances required amendment. Recommendations as provided in Annex I of the Opinions proposed amendment to the therapeutic indications, revision of the chapters on posology and method of administration, contra-indications, undesirable effects and implementation of detailed special warnings and precautions for use in a “black box”.

The Marketing Authorisation Holders of some of the anorectic agents appealed against the Opinions and grounds for appeal were received on the 15 and 30 April 1996. The grounds were against the wording in the indication, special warnings and undesirable effect sections of the excerpt from the SPC.

On the 20 June 1996, the CPMP considered the grounds for appeal and on the 17 July 1996 adopted final Opinions revising the Opinions given on the 15 February 1996. The excerpt from the SPC was revised by suppressing the word “android” in the indication, and in the special warnings and undesirable effects sections by specifying the Body Mass Index (BMI) level and amending two sentences of the previous text. All other proposals for the SPC by the CPMP remained valid.

A copy of the final Opinions for these products (Type I-III) are provided on the Internet, together with Annex I of the final Opinions which provides the amendments to be introduced into the SPCs of these medicinal products. Translations of the Opinions, with Annex I, are also provided in French, German, and Spanish.

The final Opinions were converted into Decisions by the European Commission on 9 December 1996.

Opinions following an Article 12 referral for Anorectics: Background information

Adopted Reference Number: CPMP/101-109/96

Key facts

About this medicine

• Approved name:
  Anorectics
• International non-proprietary name (INN) or common name:
  • phentermine
  • amfepramome
  • clobenzorex
  • dexfenfluramine
  • fenbutrazate
  • fenfluramine
  • fenproporex
  • mazindol
  • mefenorex
  • norpseudoephedrine
  • phenmetrazine
  • phendimetrazine
  • propylhexedrine
• Class:
  Anorectics

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/101-109/96, CPMP/111-112/96, CPMP/113-114/96
• Type:
  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:
  16/02/1996
• EC decision date:
  09/12/1996

All documents

Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Anoretics International Non-Proprietary Name (INN): Type I and Annex I

Adopted Reference Number: CPMP/101-109/96

Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Anoretics International Non-Proprietary Name (INN): Type II and Annex I

Adopted Reference Number: CPMP/111-112/96

Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Anoretics International Non-Proprietary Name (INN): Type III and Annex I

Adopted Reference Number: CPMP/113-114/96

Opinions following an Article 12 referral for Anorectics: Background information

Adopted Reference Number: CPMP/101-109/96

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.