Regulatory PathRegulatory requirements compared

Active substance

Histamine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
HISTAMINE PHOSPHATEEQ 1MG BASE/ML; EQ 0.2MG BASE/ML; EQ 0.1MG BASE/MLinjectable · injectionLILLYDiscontinued25 Apr 1939

EMA European Union — centrally authorised medicines

Ceplene Laboratoires Delbert · Authorised · authorised 7 Oct 2008 · ATC L03AX14

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HISTATROL006096922.75 MG / MLSOLUTION · PERCUTANEOUSALK-ABELLO INC
HISTATROL006097060.275 MG / MLSOLUTION · INTRADERMALALK-ABELLO INC
POSITIVE SKIN TEST CONTROL-HISTAMINE024395146 MG / MLSOLUTION · PERCUTANEOUSJUBILANT HOLLISTERSTIER LLC

Combinations containing Histamine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.