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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in March 2012 at the end of the period of market exclusivity.

On 18 October 2000, orphan designation EU/3/00/008 was granted by the European Commission to Voisin Consulting SARL, France, for arsenic trioxide for the treatment of acute promyelocytic leukaemia.

Arsenic trioxide has been authorised in the EU as Trisenox since 5 March 2002.

The sponsorship was transferred to Cell Therapeutics (UK) Ltd in 2001 and subsequently to Cephalon UK Limited, United Kingdom, in April 2006 and finally to Cephalon Europe, France, in June 2007.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Arsenic trioxide
Medicine name
Disease / condition
Treatment of acute promyelocytic leukaemia
Date of first decision
EU designation number

Sponsor's contact details

Cephalon Europe
5 rue Charles Martigny
94700 Maisons-Alfort Cedex
Tel. +33 1 49 81 82 78
Fax +33 1 49 98 13 72

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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