Zynyz: Withdrawal of the marketing authorisation application
retifanlimab
Table of contents
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.
Key facts
Name |
Zynyz |
Product number |
EMEA/H/C/005632 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/10/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal Assessment Report for Zynyz (PDF/2.09 MB)
Adopted
First published: 29/11/2021
EMA/CHMP/621679/2021 -
List item
Withdrawal letter: Zynyz (PDF/45.28 KB)
First published: 15/10/2021 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Zynyz (PDF/138.24 KB)
First published: 15/10/2021
EMA/577902/2021 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').