Tuznue: Withdrawal of the marketing authorisation application
trastuzumab
Table of contents
Overview
Prestige Biopharma Belgium BVBA withdrew its application for a marketing authorisation of Tuznue for the treatment of certain forms of breast cancer and gastric (stomach) cancer.
The company withdrew the application on 14 September 2022.
Key facts
Name |
Tuznue |
Product number |
EMEA/H/C/005066 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/09/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Tuznue (PDF/6.39 MB)
Adopted
First published: 13/12/2022
EMA/CHMP/902445/2022 -
List item
Withdrawal letter: Tuznue (PDF/89.95 KB)
First published: 14/10/2022 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Tuznue (trastuzumab) (PDF/90.61 KB)
First published: 14/10/2022
Last updated: 13/12/2022
EMA/807453/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 202214/10/2022
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24/06/2022
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20/05/2022