Amfepramone-containing medicinal products

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

Overview

Review of amfepramone medicines started

EMA has started a review of obesity medicines that contain amfepramone. These medicines are authorised in some EU countries as treatment for patients with obesity (body mass index of at least 30 kg/m2) in whom other weight-reduction methods have not worked on their own. Amfepramone medicines are authorised to be used for 4 to 6 weeks and no longer than 3 months.

A review by EMA’s safety committee (PRAC) of the recent periodic safety update report for amfepramone raised concerns that require further evaluation. The concerns include heart problems, high blood pressure in the lungs, use of the medicine for longer than 3 months, exceeding the maximum recommended dose, and use during pregnancy despite recommendations against such use.

As a result of these concerns, the Romanian medicines agency requested a review of the safety of amfepramone medicines in the context of the medicines’ benefits. EMA will communicate the PRAC’s recommendations once the review has concluded.

Key facts

About this medicine
Approved name
Amfepramone-containing medicinal products
International non-proprietary name (INN) or common name

amfepramone

Associated names
  • regenon
  • Regenon Retard
  • Tenuate
About this procedure
Current status
Procedure started
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.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
11/02/2021

All documents

Procedure started

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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