Amfepramone-containing medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
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
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Approved name |
Amfepramone-containing medicinal products
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International non-proprietary name (INN) or common name |
amfepramone |
Associated names |
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About this procedure
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Current status |
Procedure started
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Reference number |
EMEA/H/A-31/1501
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Type | |
Decision making model |
PRAC-CMDh
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Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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Procedure start date |
11/02/2021
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All documents
Procedure started
Amfepramone-containing medicinal products Article-31 referral - Notification (PDF/368.56 KB) (new)
First published: 12/02/2021
Amfepramone-containing medicinal products Article-31 referral - Annex I (PDF/127.13 KB) (new)
First published: 12/02/2021
EMA/91464/2021
Amfepramone-containing medicinal products Article-31 referral - PRAC list of questions (PDF/164.04 KB) (new)
First published: 12/02/2021
EMA/PRAC/51715/2021
Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/118.82 KB) (updated)
First published: 12/02/2021
Last updated: 25/02/2021
EMA/PRAC/51714/2021 Rev.1
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