Graspa: Withdrawal of the marketing authorisation application
asparaginase
Table of contents
Overview
On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL).
Key facts
Name |
Graspa |
Product number |
EMEA/H/C/004736 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/06/2018 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal Assessment Report for Graspa (PDF/1.95 MB)
Adopted
First published: 23/01/2019
EMA/CHMP/438029/2018 -
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Withdrawal letter: Graspa (PDF/142.34 KB)
First published: 29/06/2018
Last updated: 29/06/2018 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Graspa (L-asparaginase) (PDF/69.89 KB)
First published: 29/06/2018
Last updated: 29/06/2018
EMA/431413/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').