Basic Information
Ceplene
Regulatory Information
EMEA/H/C/000796
October 7, 2008
12
April 19, 2023
Company Information
France
Laboratoires Delbert 49 Rue Rouelle 75015 Paris
Laboratoires Delbert SAS
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
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.