Axumin: Withdrawal of the application to change the marketing authorisation
fluciclovine (18F)
Table of contents
Overview
Blue Earth Diagnostics Ireland Ltd withdrew its application for the use of Axumin in the diagnosis of glioma (a type of brain tumour) and the continuing assessment of the disease.
The company withdrew the application on 11 February 2020.
Key facts
Name |
Axumin |
Product number |
EMEA/H/C/004197 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
21/05/2017 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
11/02/2020 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Axumin (II-11) (PDF/2.95 MB)
Adopted
First published: 25/03/2020
EMA/CHMP/140420/2020 -
List item
Withdrawal letter: Axumin (II-11) (PDF/139.51 KB)
First published: 28/02/2020 -
List item
Questions and answers on the withdrawal of application to change the marketing authorisation for Axumin (fluciclovine (18F)) (II-11) (PDF/131.11 KB)
First published: 28/02/2020
Last updated: 25/03/2020
EMA/88420/2020 -
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').