EU/3/05/272: Orphan designation for the treatment of acute myeloid leukaemia

Histamine dihydrochloride

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2018 at the end of the 10-year period of market exclusivity.

On 11 April 2005, orphan designation (EU/3/05/272) was granted by the European Commission to Maxim Pharmaceuticals Europe Ltd, United Kingdom, for histamine dihydrochloride for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to EpiCept GmbH, Germany, in August 2006 and subsequently to Meda AB, Sweden, in October 2012.

Histamine dihydrochloride has been authorised in the EU as Ceplene since 7 October 2008.

The sponsorship was transferred to Noventia Pharma Srl, Italy, in December 2017.

Key facts

Active substance
Histamine dihydrochloride
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
Noventia Pharma Srl
Via Carlo Pisacane 31
47121 Forli (FC)
Tel. +39 0543 34716

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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