Doxorubicin SUN: Withdrawal of the marketing authorisation application
doxorubicin
Table of contents
Overview
On 20 Jul 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma.
Key facts
Name |
Doxorubicin SUN |
Product number |
EMEA/H/C/002049 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/07/2011 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Doxorubicin SUN (PDF/754.02 KB)
Adopted
First published: 26/09/2011
Last updated: 26/09/2011
EMA/588790/2011 -
List item
Withdrawal letter: Doxorubicin SUN (PDF/57.02 KB)
First published: 13/09/2011
Last updated: 13/09/2011
EMA/CHMP/647763/2011 -
List item
Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (PDF/50.72 KB)
First published: 21/07/2011
Last updated: 21/07/2011
EMA/587515/2011 -
List item
Withdrawal of the marketing authorisation application for Doxorubicin SUN (PDF/55.43 KB)
First published: 13/09/2011
Last updated: 13/09/2011
EMA/CHMP/647763/2011 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').