Regulatory PathRegulatory requirements compared

Active substance

Bleomycin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Bleoez15 IUpowder for solution for injection · Intravenous, Intramuscular, Subcutaneous1 VialSAR 67.90Generic · PrescriptionKorea United Pharm. IncValid
Bleomycin Venus15 USP UnitsPowder for solution for injection/infusion · Intramuscular and intravenous use1 VialSAR 63.05Generic · PrescriptionVENUS REMEDIES LIMITEDValid
BLEOCIN 15MG VIAL15 mgSolution · Intravenous use1 VialSAR 72.75NCE · PrescriptionNIPPON KAYAKUInvalid · Not Marketed
Indications — CHI Daman Drug Formulary

BURN MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIAL; EQ 30 UNITS BASE/VIALinjectable · injectionHOSPIRAPrescription10 Mar 2000
BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIAL; EQ 15 UNITS BASE/VIALinjectable · injectionHIKMA PHARMSPrescription17 Oct 2001
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIAL; EQ 30 UNITS BASE/VIALinjectable · injectionFRESENIUS KABI USAPrescription28 Jan 2008
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIAL; EQ 30 UNITS BASE/VIALinjectable · injectionMEITHEALPrescription20 Apr 2018
BLENOXANEEQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionBRISTOL MYERS SQUIBBDiscontinued31 Jul 1973
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIAL; EQ 30 UNITS BASE/VIALinjectable · injectionTEVA PARENTERALDiscontinued3 Jun 1996
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIAL; EQ 30 UNITS BASE/VIALinjectable · injectionTEVA PHARMS USADiscontinued27 Jun 2000
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALinjectable · injectionPHARMACHEMIE BVDiscontinued13 Dec 2007
BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALinjectable · injectionCIPLADiscontinued11 Mar 2019

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BLEOMYCIN FOR INJECTION0226598215 UNIT / VIALPOWDER FOR SOLUTION · INTRAPLEURAL; SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
BLEOMYCIN FOR INJECTION USP0213169215 UNIT / VIALPOWDER FOR SOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULAR; INTRA-ARTERIAL; INTRACAVITARYPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBLEOMYCIN SULFATE 15 UNIT VIAL$26.448per EA22 Apr 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.1. Cytotoxic medicines · complementary
    Kaposi sarcoma of unspecified primary site; Germ cell tumour of testis; Other specified malignant neoplasms of the ovary; Hodgkin lymphoma
    Parenteral > General injections > unspecified: 15000 IU in vial (as sulfate)

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.