Zynyz: Withdrawal of the marketing authorisation application

retifanlimab

Overview

Incyte Biosciences Distribution B.V. withdrew its application for a marketing authorisation of Zynyz for the treatment of squamous carcinoma of the anal canal, a cancer of the tissues of the anus. 

The company withdrew the application on 8 October 2021.

  • List item

    Questions and answers on the widrawal (PDF/138.24 KB)


    First published: 15/10/2021
    EMA/577902/2021

  • Key facts

    Name
    Zynyz
    Product number
    EMEA/H/C/005632
    International non-proprietary name (INN) or common name
    • retifanlimab
    Active substance
    • retifanlimab
    Date of withdrawal
    14/10/2021
    Company making the application
    Incyte Biosciences Distribution B.V.
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    1 rating