Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used during the patients’ first ‘remission’ (a period without symptoms of the disease after the first course of treatment).
AML is rare, and Ceplene was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 April 2005.
Ceplene contains the active substance histamine dihydrochloride.
Ceplene : EPAR - Medicine overview (PDF/78.21 KB)
First published: 11/11/2008
Last updated: 01/08/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Myeloid, Acute
|Anatomical therapeutic chemical (ATC) code||
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.
Noventia Pharma Srl
|Date of issue of marketing authorisation valid throughout the European Union||
Via Carlo Pisacane 31
26/07/2018 Ceplene - EMEA/H/C/000796 - R/0036
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Ceplene maintainance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
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European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011