Ceplene
What Ceplene is used for
Ceplene maintenance 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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.
Key facts
- Brand
- Ceplene
- Active substance
- histamine dihydrochloride
- Disease area
- Leukemia, Myeloid, Acute
- Medicine group
- Immunostimulants
- ATC code
- L03AX14
- Marketing authorisation holder
- Laboratoires Delbert
- Authorised in the EU since
- 2008
Official information
In the USA
Same active substance: Histamine Positive Skin Test Control, Positive Skin Test Control - Histamine
In India
- Histamine dihydrochloride: 2 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ceplene used for?
Ceplene maintenance 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.
What is the active substance in Ceplene?
Ceplene contains histamine dihydrochloride.
Who makes Ceplene?
The EU marketing authorisation holder is Laboratoires Delbert.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, EU