Garsun: Withdrawal of the marketing authorisation application
artesunate
Table of contents
Overview
B & O Pharm withdrew its application for a marketing authorisation of Garsun, intended for the treatment of severe malaria caused by Plasmodium falciparum.
The company withdrew the application on 8 December 2022.
Key facts
Name |
Garsun |
Product number |
EMEA/H/C/005718 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/12/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Garsun (artesunate) (PDF/2.76 MB)
Adopted
First published: 01/03/2023
EMA/48303/2023 -
List item
Withdrawal letter: Garsun (artesunate) (PDF/403.99 KB)
First published: 01/03/2023 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Garsun (artesunate) (PDF/145.05 KB)
First published: 01/03/2023
EMA/939492/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').