Topotecan SUN: Withdrawal of the marketing authorisation application
topotecan
Table of contents
Overview
On 3 January 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 Topotecan SUN for the treatment metastatic cancer of the ovary, small cell lung cancer and cervical cancer.
Key facts
Name |
Topotecan SUN |
Product number |
EMEA/H/C/002091 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
03/01/2011 |
Withdrawal type |
Initial authorisation |
All documents
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List item
Topotecan SUN: Withdrawal letter (PDF/32.53 KB)
First published: 23/02/2011
Last updated: 23/02/2011 -
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Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan) (PDF/47.62 KB)
First published: 17/02/2011
Last updated: 17/02/2011
EMA/134567/2011 -
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Questions and answers on the withdrawal of the marketing authorisation application for Topotecan SUN (PDF/66.59 KB)
First published: 23/02/2011
Last updated: 23/02/2011
EMA/121971/2011 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').