🇪🇺 histamine dihydrochloride and IL-2 in European Union

EMA authorised histamine dihydrochloride and IL-2 on 7 October 2008

Marketing authorisation

EMA — authorised 7 October 2008

  • Application: EMEA/H/C/000796
  • Marketing authorisation holder: Laboratoires Delbert
  • Local brand name: Ceplene
  • 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.
  • Pathway: exceptional circumstances
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is histamine dihydrochloride and IL-2 approved in European Union?

Yes. EMA authorised it on 7 October 2008.

Who is the marketing authorisation holder for histamine dihydrochloride and IL-2 in European Union?

Laboratoires Delbert holds the EU marketing authorisation.