Tidhesco

Application withdrawn

The application for this medicine has been withdrawn

ivosidenib

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The application for Tidhesco was withdrawn after EMA’s human medicines committee, CHMP, had adopted a positive opinion recommending the granting of a marketing authorisation.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 of medicine:
  Tidhesco
• Active substance:
  Ivosidenib
• International non-proprietary name (INN) or common name:
  ivosidenib
• Therapeutic area (MeSH):
  Leukemia, Myeloid, Acute
• Anatomical therapeutic chemical (ATC) code:
  L01XX62
• EMA product number:
  EMEA/H/C/006174
• Orphan:
  <p>This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see <a href="/node/69983">Orphan designation</a>.</p>
• Marketing authorisation applicant:
  Les Laboratoires Servier
• Withdrawal of application:
  27/03/2023

All Documents

Withdrawal assessment report for Tidhesco

AdoptedReference Number: EMA/173663/2023

Withdrawal letter : Tidhesco