Oportuzumab monatox DLRC Pharma Services: Withdrawal of the marketing authorisation application
oportuzumab monatox
Table of contents
Overview
DLRC Pharma Services withdrew its application for a marketing authorisation of Oportuzumab monatox DLRC Pharma Services for the treatment and prevention of recurrence of cancer of the bladder and the prevention of recurrence of papillary tumours.
The company withdrew the application on 20 August 2021.
Key facts
Name |
Oportuzumab monatox DLRC Pharma Services |
Product number |
EMEA/H/C/005730 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/08/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Oportuzumab monatox DLRC Pharma Services (PDF/5.41 MB)
Adopted
First published: 20/10/2021
EMA/CHMP/576523/2021 -
List item
Withdrawal letter: Oportuzumab monatox DLRC Pharma Services (PDF/172.79 KB)
First published: 17/09/2021 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox) (PDF/126.71 KB)
Adopted
First published: 17/09/2021
EMA/508191/2021 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').