Ceplene

RSS

histamine dihydrochloride

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 01/08/2018

Authorisation details

Product details
Name
Ceplene
Agency product number
EMEA/H/C/000796
Active substance
Histamine dihydrochloride
International non-proprietary name (INN) or common name
histamine dihydrochloride
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
L03AX14
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

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.

Orphan

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

Publication details
Marketing-authorisation holder
Noventia Pharma Srl
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
07/10/2008
Contact address
Via Carlo Pisacane 31
47121 Forli
Italy

Product information

26/07/2018 Ceplene - EMEA/H/C/000796 - R/0036

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOSTIMULANTS

Therapeutic indication

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.

Assessment history

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