Tidhesco: Withdrawal of the marketing authorisation application
Table of contents
Overview
The applicant withdrew the marketing authorisation application for Tidhesco (ivosidenib) on 27 March 2023. It was a duplicate of the application for another medicine, Tibsovo, which is now authorised for use in the European Union.
The application for Tidhesco was withdrawn after EMA’s human medicines committee, CHMP, had adopted a positive opinion recommending the granting of a marketing authorisation. At the time of withdrawal, the European Commission had not yet granted marketing authorisation for this product. Further details are included in the
withdrawal letter
.
Key facts
| Name |
Tidhesco |
| Product number |
EMEA/H/C/006174 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Date of withdrawal |
27/03/2023 |
| Company making the application | |
| Withdrawal type |
Initial authorisation |
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').