Amfepramone-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision

Table of contents

Current status
European Commission final decision

Overview

Withdrawal of marketing authorisations for amfepramone medicines within the EU

On 27 October 2022, EMA’s safety committee (PRAC) confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This followed a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these medicines.

The recommendation followed a review which found that measures to restrict the use of these medicines for safety reasons have not been sufficiently effective. It found that the medicines were being used for longer than the recommended maximum period of 3 months, thereby potentially increasing the risk of serious side effects such as pulmonary arterial hypertension (high blood pressure in the lungs) and dependency. The medicines were also being used in patients with a history of heart disease or psychiatric disorders, increasing their risk of heart and psychiatric problems. In addition, there was evidence of use during pregnancy, which could pose risks to the unborn baby. 

The review considered all available information relating to these concerns, including data from two studies on the use of amfepramone medicines in Germany and in Denmark. In addition, the PRAC received advice from a group of experts, comprising endocrinologists, cardiologists and a patient representative. 

The PRAC considered introducing further measures to minimise the risk of side effects but could not identify any that would be sufficiently effective. The PRAC therefore concluded that the benefits of amfepramone medicines do not outweigh their risks and recommended that the medicines be removed from the market in the EU.

The CMDh1 agreed with the PRAC recommendation and adopted its position by majority on 10 November 2022. The CMDh position was forwarded to the European Commission, which issued a final legally binding decision on 13 January 2023 that is applicable in all EU countries.

1 Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human

Key facts

About this medicine
Approved name
Amfepramone-containing medicinal products
International non-proprietary name (INN) or common name
amfepramone
Associated names
  • Regenon
  • Tenuate Retard
  • Amfepramon-Hormosan
  • Regenon Retard
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1501
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.
Authorisation model
Nationally authorised product(s)
Decision making model
PRAC-CMDh
Key dates and outcomes
Procedure start date
11/02/2021
PRAC recommendation date
27/10/2022
CHMP opinion/CMDh position date
10/11/2022
EC decision date
13/01/2023
Outcome
Revocation

All documents

Procedure started

Under evaluation

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Amfepramone-containing medicinal products Article-31 referral - Withdrawal of marketing authorisations for amfepramone medicines within the EU (PDF/139.83 KB)


    First published: 11/11/2022
    Last updated: 20/01/2023
    EMA/867253/2022

    • European Commission final decision

  • List item

    Amfepramone-containing medicinal products Article-31 referral - Annex I (PDF/60.95 KB)


    First published: 31/01/2023

  • List item

    Amfepramone-containing medicinal products Article-31 referral - Annex II (PDF/164.5 KB)


    First published: 31/01/2023

  • List item

    Amfepramone-containing medicinal products Article-31 referral - Assessment report (PDF/747.52 KB)


    First published: 20/01/2023
    EMA/884474/2022

  • List item

    Amfepramone-containing medicinal products Article-31 referral - Divergent positions to CMDh position (PDF/84.53 KB)


    First published: 20/01/2023

    • 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.

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