On 17 December 2010, orphan designation (EU/3/10/824) was granted by the European Commission to Merck KGaA, Germany, for N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl) amino] isonicotinamide hydrochloride for the treatment of acute myeloid leukaemia.

Key facts

Active substance
N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
Orphan decision number

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

Merck KGaA
Frankfurter Strasse 250
D-64293 Darmstadt
Telephone: +49 61 51 72 0
Telefax: +49 61 51 72 20 00

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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