Aranesp: Withdrawal of the application to change the marketing authorisation
darbepoetin alfa
Table of contents
Overview
On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.
Key facts
Name |
Aranesp |
Product number |
EMEA/H/C/000332 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
08/06/2001 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
21/02/2018 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Aranesp (PDF/10.71 MB)
Adopted
First published: 24/04/2018
Last updated: 24/04/2018
EMA/CHMP/453348/2017 -
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Withdrawal letter: Aranesp (PDF/30.6 KB)
First published: 23/03/2018
Last updated: 23/03/2018 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Aranesp (darbepoetin alfa) (PDF/84.57 KB)
First published: 23/03/2018
Last updated: 23/03/2018
EMA/165563/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').