Flynpovi: Withdrawal of the marketing authorisation application
eflornithine /
sulindac
Table of contents
Overview
Cancer Prevention Pharma (Ireland) Limited withdrew its application for a marketing authorisation of Flynpovi for the treatment of familial adenomatous polyposis.
The company withdrew the application on 12 October 2021.
Key facts
Name |
Flynpovi |
Product number |
EMEA/H/C/005043 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
12/10/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal Assessment Report for Flynpovi (PDF/8.4 MB)
Adopted
First published: 07/12/2021
EMA/CHMP/244212/2021 -
List item
Withdrawal letter: Flynpovi (PDF/485.55 KB)
First published: 12/11/2021 -
List item
Questions and answers on the refusal of the marketing authorisation for Flynpovi (eflornithine / sulindac) (PDF/106.52 KB)
Adopted
First published: 23/07/2021
EMA/350828/2021 Rev.1 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Flynpovi (eflornithine / sulindac) (PDF/122.98 KB)
First published: 12/11/2021
EMA/627715/2021 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
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23/07/2021
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25/06/2021