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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2011 on request of the sponsor.

On 23 March 2010, orphan designation (EU/3/10/729) was granted by the European Commission to Merck KGaA, Germany, for (1S, 2S, 3R, 4R)-3-(5-fluoro-2-(3-methyl-4-(4-methylpiperazin-1-yl)-phenylamino)-pyrimidin-4-ylamino)-bicyclo[2.2.1]hept-5-ene-2-carboxamide benzoate for the treatment of acute myeloid leukaemia.

Key facts

Active substance
(1S, 2S, 3R, 4R)-3-(5-Fluoro-2-(3-methyl-4-(4-methylpiperazin-1-yl)-phenylamino)-pyrimidin-4-ylamino)-bicyclo[2.2.1]hept-5-ene-2-carboxamide benzoate
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
Orphan decision number

Sponsor's contact details

Merck KGaA
Frankfurter Str. 250
64293 Darmstadt
Telephone: +49 61 51 72 70 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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