Imcivree: Withdrawal of the application to change the marketing authorisation

setmelanotide

Overview

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.

  • List item

    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
    EMA/687359/2022

  • Key facts

    Name
    Imcivree
    Product number
    EMEA/H/C/005089
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    16/07/2021
    International non-proprietary name (INN) or common name
    • setmelanotide
    Active substance
    • Setmelanotide
    Date of withdrawal
    22/04/2022
    Company making the application
    Rhythm Pharmaceuticals Netherlands B.V.
    Withdrawal type
    Post-authorisation

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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