Exkivity: Withdrawal of the marketing authorisation application
mobocertinib
Table of contents
Overview
Takeda Pharma A/S withdrew its application for a conditional marketing authorisation of Exkivity (mobocertinib) for the treatment of a certain type of lung cancer.
The company withdrew the application on 20 July 2022.
Key facts
Name |
Exkivity |
Product number |
EMEA/H/C/005621 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/07/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Exkivity (PDF/8.8 MB)
Adopted
First published: 24/11/2022
EMA/787858/2022 -
List item
Withdrawal letter: Exkivity (PDF/145.76 KB)
First published: 19/08/2022 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Exkivity (mobocertinib) (PDF/142.38 KB)
First published: 19/08/2022
Last updated: 24/11/2022
EMA/665807/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').