Is Dacarbazine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Dacarbazine, including Dacarbazine Venus (200 mg, Lyophilisate for solution for injection, SAR 70.90); Dacarbazine medac (100 mg, Powder for solution for infusion, SAR 506.70); Dacarbazine medac (200 mg, Powder for solution for injection/infusion, SAR 1013.40); Dacarbazine medac (500 mg, Powder for solution for injection/infusion, SAR 244.50).

Is Dacarbazine approved by the US FDA?

Drugs@FDA lists 10 application product lines for Dacarbazine, including DACARBAZINE (Prescription); DACARBAZINE (Prescription); DACARBAZINE (Prescription); DTIC-DOME (Discontinued); DACARBAZINE (Discontinued).

Is Dacarbazine on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Hodgkin lymphoma.

Active substance

Dacarbazine

SFDA 6
US FDA 10
Health Canada 1
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Dacarbazine Venus	200 mg	Lyophilisate for solution for injection · Intravenous use	1 Vial	SAR 70.90	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
Dacarbazine medac	100 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 506.70	NCE · Prescription	MEDAC	Valid
Dacarbazine medac	200 mg	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 1013.40	NCE · Prescription	MEDAC	Valid
Dacarbazine medac	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 244.50	NCE · Prescription	MEDAC	Valid
DETICENE 100MG I.V VIAL+SOLV 10ML AMP	100 mg	Solution · Intravenous use	1 Vial	SAR 13.50	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
DETICENE 200MG I.V VIAL	200 mg	Solution · Intravenous use	1 Vial	SAR 28.20	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HODGKIN'S LYMPHOMA; MELANOMA; PARATHYROID CANCER; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; THYROID CANCER-MEDULLARY CARCINOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
DACARBAZINE	500MG/VIAL; 200MG/VIAL	injectable · injection	MEITHEAL	Prescription	27 Aug 1998
DACARBAZINE	100MG/VIAL; 200MG/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	27 Aug 1999
DACARBAZINE	200MG/VIAL; 500MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	15 Jun 2001
DTIC-DOME	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 200MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	BAYER HLTHCARE	Discontinued	27 May 1975
DACARBAZINE	100MG/VIAL	injectable · injection	ABRAXIS PHARM	Discontinued	28 Aug 1986
DACARBAZINE	200MG/VIAL	injectable · injection	ABRAXIS PHARM	Discontinued	28 Aug 1986
DACARBAZINE	200MG/VIAL	injectable · injection	HOSPIRA	Discontinued	18 Oct 2001
DACARBAZINE	100MG/VIAL	injectable · injection	QUAD PHARMS	Discontinued
DACARBAZINE	200MG/VIAL	injectable · injection	QUAD PHARMS	Discontinued
DACARBAZINE	500MG/VIAL	injectable · injection	QUAD PHARMS	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DACARBAZINE FOR INJECTION BP	02241445	600 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Hodgkin lymphoma
Parenteral > General injections > IV: 100 mg in vial powder for injection; 200 mg in vial powder for injection

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.