An overview of Ceplene and why it is authorised in the EU
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.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Noventia Pharma Srl
|Date of issue of marketing authorisation valid throughout the European Union||
26/07/2018 Ceplene - EMEA/H/C/000796 - R/0036
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.
European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories13/12/2011
European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories09/12/2011
European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011