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.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2020 on request of the Sponsor.

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 first decision
EU designation 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:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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