Nilotinib

Sold as Tasigna, Pantrello, Tilomia, Tasicap, Tasileuk, Nilotinib DRL

C₂₈H₂₂F₃N₇O529.50 g/mol

4-Methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide

Drag to rotate. Structure from PubChem CID 644241.

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Registration

Applicants: 3
Registrations: 12
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Novartis South Africa (Pty) Ltd	Tasigna, Pantrello	150 mg, 200 mg	410973, 450410, 500452, 500453	S4	None
Hetero Drugs South Africa (Pty) Ltd	Tilomia, Tasicap, Tasileuk	150, 200	540274, 540275, 540276.274, 540277.275, 540278.274, 540279.275	S4	PI PIL
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd	Nilotinib DRL	150, 200	590508, 590509	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Tasigna 200 MG EACH CAPSULE CONTAINS: NILOTINIB HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO NILOTINIB 200,0 mg	200 mg	41097341/26/0973	Registered	S4	None
Tasigna 150 MG EACH CAPSULE CONTAINS: NILOTINIB HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO NILOTINIB 150,0 mg	150 mg	45041045/26/0410	Registered	S4	None
Pantrello 150 MG EACH CAPSULE CONTAINS: NILOTINIB HYDROCHLORIDE EQUIVALENT TO NILOTINIB 150,0 mg	150 mg	50045250/26/0452	Registered	S4	None
Pantrello 200 MG EACH CAPSULE CONTAINS :NILOTINIB HYDROCHLORIDE EQUIVALENT TO NILOTINIB 200,0 mg	200 mg	50045350/26/0453	Registered	S4	None
Tilomia 150 EACH CAPSULE CONTAINS NILOTINIB 150,0 mg	150Capsules	54027454/26/0274Approved 28 April 2021	Registered	S4	PI PIL
Tilomia 200 EACH CAPSULE CONTAINS NILOTINIB 200,0 mg	200Capsules	54027554/26/0275Approved 28 April 2021	Registered	S4	PI PIL
Tasicap 150 EACH CAPSULE CONTAINS NILOTINIB 150,0 mg	150Capsules.	540276.27454/26/0276.274Approved 28 April 2021	Registered	S4	PI PIL
Tasicap 200 EACH CAPSULE CONTAINS NILOTINIB 200,0 mg	200Capsules.	540277.27554/26/0277.275Approved 28 April 2021	Registered	S4	PI PIL
Tasileuk 150 EACH CAPSULE CONTAINS NILOTINIB 150,0 mg	150Capsules.	540278.27454/26/0278.274Approved 25 April 2021	Registered	S4	PI PIL
Tasileuk 200 EACH CAPSULE CONTAINS NILOTINIB 200,0 mg	200Capsules.	540279.27554/26/0279.275Approved 25 April 2021	Registered	S4	PI PIL
Nilotinib 150 DRL EACH CAPSULE CONTAINS: NILOTINIB HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO NILOTINIB 150,0 mg	150Capsule	59050859/26/0508Approved 2 June 2026	Registered	S4	PI PIL
Nilotinib 200 DRL EACH CAPSULE CONTAINS: NILOTINIB HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO NILOTINIB 200,0 mg	200	59050959/26/0509	Registered	S4	None

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S4, matched to the Consolidated Schedules by ingredient, confidence high.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Nilotinib

S4: Nilotinib
Consolidated Schedules 06 July 2026, line 7267

Pharmacological class: Cytostatic agents (class 26)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Professional information (PI)For healthcare professionalsTilomia 150, Hetero Drugs South Africa (Pty) Ltd Patient information leaflet (PIL)For patients and carersTilomia 150, Hetero Drugs South Africa (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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