Is Dasatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 23 valid registrations of Dasatinib, including DASATINIB NEAPOLIS (140 mg, Film-coated tablet, SAR 2984.10); ELPIDA (20 mg, Film-coated tablet, SAR 4752.95); ELPIDA (140 mg, Film-coated tablet, SAR 7302.90); ELPIDA 50MG FILM COATED TABLET (50 mg, Film-coated tablet, SAR 7083.80); ELPIDA 70MG FILM COATED TABLET (70 mg, Film-coated tablet, SAR 7302.90).

Is Dasatinib approved by the US FDA?

Drugs@FDA lists 13 application product lines for Dasatinib, including SPRYCEL (Prescription); SPRYCEL (Prescription); DASATINIB (Prescription); DASATINIB (Prescription); PHYRAGO (Prescription).

Is Dasatinib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Dasatinib: Sprycel, Dasatinib Accord Healthcare.

Is Dasatinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Chronic myelogenous leukaemia, BCR-ABL1-positive.

Are there safety signals or safety updates for Dasatinib?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2025-08-01).

Active substance

Dasatinib

SFDA 26
US FDA 13
EMA 4
Health Canada 27
US price lines 2
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DASATINIB NEAPOLIS	140 mg	Film-coated tablet · Oral use	30 Blister	SAR 2984.10	Generic · Prescription	LES LABORATORIES NEAPOLIS PHARMA	Valid
ELPIDA	20 mg	Film-coated tablet · Oral use	60 Blister	SAR 4752.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ELPIDA	140 mg	Film-coated tablet · Oral use	30 Blister	SAR 7302.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ELPIDA 50MG FILM COATED TABLET	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 7083.80	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ELPIDA 70MG FILM COATED TABLET	70 mg	Film-coated tablet · Oral use	60 Blister	SAR 7302.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Fylibix	20 mg	Film-coated tablet · Oral use	60 Blister	SAR 2984.75	Generic · Prescription	HEXAL AG	Valid
Fylibix	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 5968.05	Generic · Prescription	HEXAL AG	Valid
Fylibix	70 mg	Film-coated tablet · Oral use	60 Blister	SAR 5968.05	Generic · Prescription	HEXAL AG	Valid
Otrasa	20 mg	Film-coated tablet · Oral use	60 Blister	SAR 5003.10	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otrasa	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 8285.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otrasa	70 mg	Film-coated tablet · Oral use	60 Blister	SAR 8541.40	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otrasa	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 4270.70	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otrasa	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 8285.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Otrasa	140 mg	Film-coated tablet · Oral use	30 Blister	SAR 8541.40	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
SPRYCEL 20MG F.C. TABLETS	20 mg	Film-coated tablet · Oral use	60 Bottle	SAR 6157.65	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid
SPRYCEL 50MG F.C. TABLETS	50 mg	Film-coated tablet · Oral use	60 Bottle	SAR 9747.25	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid
SPRYCEL 70MG F.C. TABLETS	70 mg	Film-coated tablet · Oral use	60 Bottle	SAR 10048.70	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid
Sprynat	140 mg	Tablet · Oral use	30 Blister	SAR 2556.40	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Sprynat	70 mg	Tablet · Oral use	60 Blister	SAR 5112.75	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Sprynat	50 mg	Tablet · Oral use	60 Blister	SAR 4959.40	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
TYKODAS	50 mg	Film-coated tablet · Oral use	60 Blister	SAR 5219.65	Generic · Prescription	Boston Oncology Arabia	Valid
TYKODAS	70 mg	Film-coated tablet · Oral use	60 Blister	SAR 5381.05	Generic · Prescription	Boston Oncology Arabia	Valid
TYKODAS	100 mg	Film-coated tablet · Oral use	60 Blister	SAR 10439.30	Generic · Prescription	Boston Oncology Arabia	Valid
SPRYCEL 20MG F.C. TABLETS	20 mg	Film-coated tablet · Oral use	60 Bottle	SAR 7697.05	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
SPRYCEL 50MG F.C. TABLETS	50 mg	Film-coated tablet · Oral use	60 Bottle	SAR 16035.50	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

1 more — full table

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); CHRONIC MYELOID LEUKAEMIA (CML); PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)

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

Product	Strength	Form · route	Applicant	Status	First approved
SPRYCEL	20MG; 50MG; 70MG; 100MG; 80MG; 140MG	tablet · oral	BRISTOL MYERS SQUIBB	Prescription	28 Jun 2006
SPRYCEL	70MG	tablet · oral	BRISTOL MYERS SQUIBB	Prescription	28 Jun 2006
DASATINIB	20MG; 50MG; 70MG; 100MG	tablet · oral	APOTEX	Prescription	10 Jun 2016
DASATINIB	80MG; 140MG	tablet · oral	APOTEX	Prescription	23 Nov 2021
PHYRAGO	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	HANDA THERAP	Prescription	5 Dec 2023
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	DR REDDYS	Prescription	3 Mar 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	BIOCON PHARMA	Prescription	3 Mar 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	ZYDUS PHARMS	Prescription	3 Mar 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	EUGIA PHARMA	Prescription	22 Apr 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	LUPIN	Prescription	25 Aug 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	TEVA PHARMS USA	Prescription	27 Aug 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	ALEMBIC	Prescription	6 Nov 2025
DASATINIB	20MG; 50MG; 70MG; 80MG; 100MG; 140MG	tablet · oral	MSN	Prescription	11 Sep 2026

EMA European Union — centrally authorised medicines

Sprycel Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 20 Nov 2006 · ATC L01EA02

Therapeutic indication (EMA)

Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

Dasatinib Accord Healthcare Accord Healthcare S.L.U. · Authorised · authorised 26 Jul 2024 · ATC L01EA02

Therapeutic indication (EMA)

Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.

Dasatinib Accordpharma Accord Healthcare S.L.U. · Withdrawn · authorised 24 Mar 2022 · ATC L01EA02

Therapeutic indication (EMA)

Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.

Dasatinib Accord Accord Healthcare S.L.U. · Withdrawn · authorised 24 Mar 2022 · ATC L01EA02

Therapeutic indication (EMA)

Dasatinib Accord is indicated for the treatment of adult patients with: • Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib Accord is indicated for the treatment of paediatric patients with: • newly diagnosed Ph+ ALL in combination with chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DASATINIB	02470705	20 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB	02470713	50 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB	02470721	100 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB	02481499	70 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB	02481502	80 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB TABLETS	02562464	20 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB TABLETS	02562472	50 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB TABLETS	02562480	70 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB TABLETS	02562499	80 MG	TABLET · ORAL	APOTEX INC
APO-DASATINIB TABLETS	02562502	100 MG	TABLET · ORAL	APOTEX INC
SPRYCEL	02293129	20 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
SPRYCEL	02293137	50 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
SPRYCEL	02293145	70 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
SPRYCEL	02320193	100 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
SPRYCEL	02360810	80 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
SPRYCEL	02360829	140 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
TARO-DASATINIB	02499282	20 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-DASATINIB	02499304	50 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-DASATINIB	02499312	70 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-DASATINIB	02499320	80 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-DASATINIB	02499339	100 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-DASATINIB	02499347	140 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TEVA-DASATINIB	02478307	20 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-DASATINIB	02478315	50 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-DASATINIB	02478323	70 MG	TABLET · ORAL	TEVA CANADA LIMITED

2 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DASATINIB 100 MG TABLET	$26.45683	per EA	30 Sep 2026
US NADAC	SPRYCEL 100 MG TABLET	$591.1812	per EA	20 May 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)

8.2.2. Targeted therapies · complementary
Chronic myelogenous leukaemia, BCR-ABL1-positive
Oral > Solid: 20 mg tablet; 50 mg tablet; 70 mg tablet; 80 mg tablet; 100 mg tablet (EML); 140 mg tablet (EML)

Safety signals and safety-related labeling changes

US FDA 1 Aug 2025 PHYRAGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 31 Jul 2024 SPRYCEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Apr 2018 PRAC signal: Cytomegalovirus (CMV) reactivation
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2017 PRAC signal: Cytomegalovirus (CMV) reactivation
Action for MAH: update of the product information: No
EMA PRAC 9 Jun 2017 PRAC signal: Serious adverse drug reactions (ADRs) including bleeding events following potential drug interaction between dasatinib and warfarin
Action for MAH: update of the product information: No

All safety entries for dasatinib →

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.