Ceplene (histamine dihydrochloride)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- histamine dihydrochloride
- Company
- Laboratoires Delbert
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- EU approval
- Tue 07 Oct 2008
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000796
- ATC
- L03AX14
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.