Is Bosutinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Bosutinib, including BOSULIF (100 mg, Film-coated tablet, SAR 2635.55); BOSULIF TABLETS (400 mg, Film-coated tablet, SAR 7224.30); BOSULIF TABLETS (500 mg, Film-coated tablet, SAR 9030.40); VOLOPEM (500 mg, Film-coated tablet, SAR 9030.40); VOLOPEM (100 mg, Film-coated tablet, SAR 2635.55).

Is Bosutinib approved by the US FDA?

Drugs@FDA lists 4 application product lines for Bosutinib, including BOSULIF (Prescription); BOSULIF (Prescription); BOSUTINIB MONOHYDRATE (Prescription); BOSUTINIB MONOHYDRATE (Prescription).

Is Bosutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bosutinib: Bosulif.

Are there safety signals or safety updates for Bosutinib?

EMA PRAC: 4 entries; US FDA: 2 entries (latest 2026-03-02).

Active substance

Bosutinib

SFDA 5
US FDA 4
EMA 1
Health Canada 4
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BOSULIF	100 mg	Film-coated tablet · Oral use	28 Blister	SAR 2635.55	NCE · Prescription	Pfizer Europe MA EEIG	Valid
BOSULIF TABLETS	400 mg	Film-coated tablet · Oral use	28 Blister	SAR 7224.30	NCE · Prescription	PFIZER SAUDI LIMITED	Valid
BOSULIF TABLETS	500 mg	Film-coated tablet · Oral use	28 Blister	SAR 9030.40	NCE · Prescription	PFIZER SAUDI LIMITED	Valid
VOLOPEM	500 mg	Film-coated tablet · Oral use	28 Blister	SAR 9030.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
VOLOPEM	100 mg	Film-coated tablet · Oral use	28 Blister	SAR 2635.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

CHRONIC MYELOID LEUKAEMIA (CML)

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

Product	Strength	Form · route	Applicant	Status	First approved
BOSULIF	EQ 100MG BASE; EQ 500MG BASE; EQ 400MG BASE	tablet · oral	PF PRISM CV	Prescription	4 Sep 2012
BOSULIF	EQ 50MG BASE; EQ 100MG BASE	capsule · oral	PF PRISM CV	Prescription	26 Sep 2023
BOSUTINIB MONOHYDRATE	EQ 100MG BASE; EQ 500MG BASE	tablet · oral	ALEMBIC	Prescription	23 May 2025
BOSUTINIB MONOHYDRATE	EQ 400MG BASE	tablet · oral	MSN	Prescription	12 Jun 2026

EMA European Union — centrally authorised medicines

Bosulif Pfizer Europe MA EEIG · Authorised · authorised 27 Mar 2013 · ATC L01EA04

Therapeutic indication (EMA)

Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BOSULIF	02419149	100 MG	TABLET · ORAL	PFIZER CANADA ULC
BOSULIF	02419157	500 MG	TABLET · ORAL	PFIZER CANADA ULC
REDDY-BOSUTINIB	02560038	100 MG	TABLET · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-BOSUTINIB	02560046	500 MG	TABLET · ORAL	DR REDDY'S LABORATORIES LTD

Safety signals and safety-related labeling changes

US FDA 2 Mar 2026 BOSULIF — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Mar 2026 BOSULIF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
EMA PRAC 30 Oct 2025 PRAC signal: Cutaneous vasculitis
Action for MAH: update of the product information: Yes
EMA PRAC 10 Jul 2025 PRAC signal: Cutaneous vasculitis
Action for MAH: update of the product information: No
EMA PRAC 9 Feb 2023 PRAC signal: Interstitial lung disease (ILD)
Action for MAH: update of the product information: Yes
EMA PRAC 29 Sep 2022 PRAC signal: Interstitial lung disease (ILD)
Action for MAH: update of the product information: No

All safety entries for bosutinib →

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.