Current status:
European Commission final decision


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.

Key facts

Approved name
International non-proprietary name (INN) or common name
amfepramome, clobenzorex, dexfenfluramine, fenbutrazate, fenfluramine, fenproporex, mazindol, mefenorex, norpseudoephedrine, phenmetrazine, phendimetrazine, phentermine and propylhexedrine
Reference number
CPMP/101-109/96, CPMP/111-112/96, CPMP/113-114/96
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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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