Vynpenta (previously AvacopanChemoCentryx): Withdrawal of the marketing authorisation application
Table of contents
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 |
Active substance |
|
Date of withdrawal |
23/01/2019 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Vynpenta (PDF/6.31 MB)
First published: 15/05/2020
EMA/CHMP/570808/2019 -
List item
Withdrawal letter : Vynpenta (PDF/127.65 KB)
First published: 01/02/2019 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Vynpenta (avacopan) (PDF/71.5 KB)
First published: 01/02/2019
Last updated: 15/05/2020
EMA/38410/2019 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').