Gavreto: Withdrawal of the application to change the marketing authorisation

pralsetinib

Overview

Roche Registration GmbH withdrew its application for the use of Gavreto in certain types of thyroid cancer.

The company withdrew the application on 3 November 2022.

  • List item

    Questions and answers on the withdrawal of application to change the marketing authorisation for Gavreto (pralsetinib) (II-0002-G) (PDF/143.25 KB) (updated)


    First published: 11/11/2022
    Last updated: 02/02/2023
    EMA/876364/2022

  • Key facts

    Name
    Gavreto
    Product number
    EMEA/H/C/005413
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    18/11/2021
    International non-proprietary name (INN) or common name
    • pralsetinib
    Active substance
    • pralsetinib
    Date of withdrawal
    03/11/2022
    Company making the application
    Roche Registration GmbH 
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

    How useful was this page?

    Add your rating