EU/3/16/1640

About

This medicine is now known as enasidenib.

On 28 April 2016, orphan designation (EU/3/16/1640) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate for the treatment of acute myeloid leukaemia.

Key facts

Active substance
2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate (enasidenib)
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
28/04/2016
Outcome
Positive
Orphan decision number
EU/3/16/1640

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Celgene Europe Limited
1 Longwalk Road
Stockley Park
Uxbridge
Middlesex UB11 1DB
United Kingdom
Tel. +44 (0)20 8831 8300
Fax +44 (0)20 8831 8301
E-mail: medinfo.uk.ire@celgene.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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