Sitoiganap: Withdrawal of the marketing authorisation application
autologous glioma tumor cell lysates (inactivated) /
allogeneic glioma tumor cell lysates (inactivated) /
allogeneic glioma tumor cells (inactivated) /
autologous glioma tumor cells (inactivated)
Table of contents
Overview
Epitopoietic Research Corporation-Belgium (E.R.C.) withdrew its application for a marketing authorisation of Sitoiganap to treat adults with a type of brain cancer called malignant glioma, that is progressive (continues to grow) or recurrent (has come back) after treatment.
The company withdrew the application on 2 May 2022.
Key facts
Name |
Sitoiganap |
Product number |
EMEA/H/C/003693 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
02/05/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Sitoiganap (PDF/1.6 MB)
Adopted
First published: 17/06/2022
EMA/352570/2022 -
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Withdrawal letter: Sitoiganap (PDF/13.66 KB)
First published: 20/05/2022 -
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Questions and answers on the withdrawal of application for the marketing authorisation of Sitoiganap (allogeneic and autologous haptenised and irradiated cells and cell lysates derived from glioma) (PDF/106.74 KB)
First published: 20/05/2022
EMA/266354/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').