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.

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
31/01/2019
Company making the application
ChemoCentryx Ltd
Withdrawal type
Initial authorisation

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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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