Is Nilotinib 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 Nilotinib, including Nilo (200 mg, Capsule, SAR 2673.10); Nilo (150 mg, Capsule, SAR 2108.95); TASIGNA 150MG CAPSULES (150 mg, Capsule, SAR 9038.45); TASIGNA 200MG CAPSULES (200 mg, Capsule, SAR 11456.25).

Is Nilotinib approved by the US FDA?

Drugs@FDA lists 9 application product lines for Nilotinib, including TASIGNA (Prescription); NILOTINIB HYDROCHLORIDE (Prescription); DANZITEN (Prescription); NILOTINIB HYDROCHLORIDE (Prescription); NILOTINIB HYDROCHLORIDE (Prescription).

Is Nilotinib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Nilotinib: Tasigna, Nilotinib Accord.

Is Nilotinib 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 Nilotinib?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2026-04-14).

Active substance

Nilotinib

SFDA 4
US FDA 9
EMA 2
Health Canada 6
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Nilo	200 mg	Capsule · Oral use	28 Bottle	SAR 2673.10	Generic · Prescription	Saudi Amarox	Valid
Nilo	150 mg	Capsule · Oral use	28 Bottle	SAR 2108.95	Generic · Prescription	Saudi Amarox	Valid
TASIGNA 150MG CAPSULES	150 mg	Capsule · Oral use	112 Blister	SAR 9038.45	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
TASIGNA 200MG CAPSULES	200 mg	Capsule · Oral use	112 Blister	SAR 11456.25	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid

Indications — CHI Daman Drug Formulary

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

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

Product	Strength	Form · route	Applicant	Status	First approved
TASIGNA	EQ 200MG BASE; EQ 150MG BASE; EQ 50MG BASE	capsule · oral	NOVARTIS	Prescription	29 Oct 2007
NILOTINIB HYDROCHLORIDE	EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE	capsule · oral	APOTEX	Prescription	5 Jan 2024
DANZITEN	EQ 71MG BASE; EQ 95MG BASE	tablet · oral	AZURITY	Prescription	7 Nov 2024
NILOTINIB HYDROCHLORIDE	EQ 150MG BASE; EQ 200MG BASE	capsule · oral	HETERO LABS LTD V	Prescription	19 Nov 2025
NILOTINIB HYDROCHLORIDE	EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE	capsule · oral	DR REDDYS	Prescription	19 Nov 2025
NILOTINIB HYDROCHLORIDE	EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE	capsule · oral	MSN	Prescription	19 Nov 2025
NILOTINIB HYDROCHLORIDE	EQ 150MG BASE; EQ 200MG BASE	capsule · oral	TORRENT	Prescription	15 Dec 2025
CAVHANZA	60MG; 80MG	tablet, orally disintegrating · oral	CYCLE	Prescription	29 May 2026
NILOTINIB HYDROCHLORIDE	EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE	capsule · oral	TEVA PHARMS INC	Prescription	26 Jun 2026

EMA European Union — centrally authorised medicines

Tasigna Novartis Europharm Limited · Authorised · authorised 19 Nov 2007 · ATC L01EA03

Therapeutic indication (EMA)

Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Nilotinib Accord Accord Healthcare S.L.U. · Authorised · authorised 22 Aug 2024 · ATC L01EA03

Therapeutic indication (EMA)

Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-NILOTINIB	02550881	150 MG	CAPSULE · ORAL	APOTEX INC
APO-NILOTINIB	02550903	200 MG	CAPSULE · ORAL	APOTEX INC
REDDY-NILOTINIB	02556634	150 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
REDDY-NILOTINIB	02556642	200 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
TASIGNA	02315874	200 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TASIGNA	02368250	150 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Chronic myelogenous leukaemia, BCR-ABL1-positive
Oral > Solid > capsule: 150 mg; 200 mg

Safety signals and safety-related labeling changes

US FDA 14 Apr 2026 DANZITEN — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Feb 2024 TASIGNA — 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
EMA PRAC 28 Nov 2019 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No

All safety entries for nilotinib →

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.