Imcivree: Withdrawal of the application to change the marketing authorisation
Table of contents
Rhythm Pharmaceuticals Netherlands B.V. withdrew its application for the use of Imcivree to treat obesity and control hunger associated with genetically confirmed Alström syndrome.
The company withdrew the application on 22 April 2022.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Imcivree (PDF/5.1 MB)Adopted
First published: 28/09/2022
Withdrawal letter: Imcivree (PDF/112.23 KB)
First published: 21/07/2022
Questions and answers on the withdrawal of application to change the marketing authorisation for Imcivree (setmelanotide) (PDF/97.64 KB)
First published: 22/07/2022
Last updated: 28/09/2022
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').