Vynpenta (previously AvacopanChemoCentryx):

Withdrawal of the marketing authorisation application

avacopan

Overview

On 23 January 2019, ChemoCentryx officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a conditional marketing authorisation for Vynpenta (avacopan) for the treatment of the blood vessel disorders granulomatosis with polyangiitis and microscopic polyangiitis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Vynpenta (avacopan) (PDF/71.5 KB) (updated)


    First published: 01/02/2019
    Last updated: 15/05/2020
    EMA/38410/2019

  • Key facts

    Name
    Vynpenta (previously AvacopanChemoCentryx)
    Product number
    EMEA/H/C/004487
    International non-proprietary name (INN) or common name
    • avacopan
    Active substance
    • Avacopan
    Date of withdrawal
    23/01/2019
    Company making the application
    ChemoCentryx Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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