Is Busulfan 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 Busulfan, including BUSULCAN 6 mg/ml Vial (6 mg/ml, Solution, SAR 7359.00); Busulfan BOS (6 mg/ml, Concentrate for solution for infusion, SAR 6377.80); MYLERAN (2 mg, Tablet, SAR 877.25); Sulbus 60 mg per 10 ml (6 mg/ml, Concentrate for solution for infusion, SAR 6868.40).

Is Busulfan approved by the US FDA?

Drugs@FDA lists 17 application product lines for Busulfan, including MYLERAN (Prescription); BUSULFEX (Prescription); BUSULFAN (Prescription); BUSULFAN (Prescription); BUSULFAN (Prescription).

Is Busulfan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Busulfan: Busulfan Fresenius Kabi.

Are there safety signals or safety updates for Busulfan?

US FDA: 1 entry (latest 2018-09-28).

Active substance

Busulfan

SFDA 6
US FDA 17
EMA 2
Health Canada 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BUSULCAN 6 mg/ml Vial	6 mg/ml	Solution · Intravenous use	8 Vial	SAR 7359.00	NCE · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Busulfan BOS	6 mg/ml	Concentrate for solution for infusion · Intravenous use	8 Vial	SAR 6377.80	Generic · Prescription	Boston Oncology Arabia	Valid
MYLERAN	2 mg	Tablet · Oral use	100 Tablet Container	SAR 877.25	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
Sulbus 60 mg per 10 ml	6 mg/ml	Concentrate for solution for infusion · Intravenous use	8 Vial	SAR 6868.40	Generic · Prescription	Accord Healthcare Limited	Valid
MYLERAN	2 mg	Tablet · Oral use	100 Tablet Container	SAR 31.35	NCE · Prescription	GLAXOWELLCOME	Withdrawn by regulatory authority · Not Marketed
MYLERAN	2 mg	Tablet · Oral use	100 Tablet Container	SAR 1037.55	NCE · Prescription	ASPEN	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); Neuroblastoma; POLYCYTHEMIA VERA

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

Product	Strength	Form · route	Applicant	Status	First approved
MYLERAN	2MG	tablet · oral	WAYLIS THERAP	Prescription	26 Jun 1954
BUSULFEX	6MG/ML	injectable · injection	OTSUKA PHARM	Prescription	4 Feb 1999
BUSULFAN	6MG/ML	injectable · injection	PHARMASCIENCE INC	Prescription	24 Mar 2017
BUSULFAN	6MG/ML	injectable · injection	AMNEAL	Prescription	18 Dec 2017
BUSULFAN	6MG/ML	injectable · injection	HOSPIRA	Prescription	31 Jul 2018
BUSULFAN	6MG/ML	injectable · injection	ACCORD HLTHCARE INC	Prescription	22 Feb 2019
BUSULFAN	6MG/ML	injectable · injection	ADAPTIS	Prescription	18 Apr 2019
BUSULFAN	6MG/ML	injectable · injection	MEITHEAL	Prescription	23 Oct 2020
BUSULFAN	6MG/ML	injectable · injection	PRINSTON INC	Prescription	11 Sep 2024
BUSULFAN	6MG/ML	injectable · injection	AM REGENT	Discontinued	22 Dec 2015
BUSULFAN	6MG/ML	injectable · injection	MYLAN INSTITUTIONAL	Discontinued	20 Nov 2017
BUSULFAN	6MG/ML	injectable · injection	ACTAVIS	Discontinued	8 Dec 2017
BUSULFAN	6MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	13 Jul 2018
BUSULFAN	6MG/ML	injectable · injection	QUAGEN	Discontinued	21 Sep 2018
BUSULFAN	6MG/ML	injectable · injection	NEXUS	Discontinued	14 Jan 2019
BUSULFAN	6MG/ML	injectable · injection	APOTEX	Discontinued	7 May 2019
BUSULFAN	6MG/ML	injectable · injection	EUGIA PHARMA	Discontinued	25 Jun 2024

EMA European Union — centrally authorised medicines

Busulfan Fresenius Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 22 Sep 2014 · ATC L01AB01

Therapeutic indication (EMA)

Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

Busilvex Pierre Fabre Medicament · Withdrawn · authorised 9 Jul 2003 · ATC L01AB01

Therapeutic indication (EMA)

Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BUSULFAN FOR INJECTION	02463733	60 MG / 10 ML	SOLUTION · INTRAVENOUS	STERIMAX INC
MYLERAN	00004618	2 MG	TABLET · ORAL	ASPEN PHARMACARE CANADA INC.
PMS-BUSULFAN	02477343	6 MG / ML	SOLUTION · INTRAVENOUS	PHARMASCIENCE INC

Safety signals and safety-related labeling changes

US FDA 28 Sep 2018 BUSULFEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for busulfan →

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.