TASIGNA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug TASIGNA contains one active pharmaceutical ingredient (API):

1 Nilotinib UNII 5JHU0N1R6K - NILOTINIB HYDROCHLORIDE MONOHYDRATE

Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein. Nilotinib selectively inhibits the proliferation and induces apoptosis in cell lines and in primary Philadelphia-chromosome positive leukaemia cells from CML patients. In murine models of CML, as a single agent nilotinib reduces tumour burden and prolongs survival following oral administration. Read about Nilotinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TASIGNA 50/200mg Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01EA03	Nilotinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EA BCR-ABL tyrosine kinase inhibitors
Discover more medicines within L01EA03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 1309X, 9171Q
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526514070079204, 526516060086803
Country: CA	Health Products and Food Branch	Identifier(s): 02315874, 02368250, 02481715
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 29981-09-11, 361300812
Country: EE	Ravimiamet	Identifier(s): 1342189, 1342190, 1510276, 1510287, 1588495, 1588507, 1588518, 1588529, 1722473, 1722484, 1756919
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 07422003, 07422006
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 113818, 155287, 523758
Country: FR	Base de données publique des médicaments	Identifier(s): 63690098, 66460565, 69596691
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 135994, 184487, 371419
Country: HK	Department of Health Drug Office	Identifier(s): 56797, 60833, 66002
Country: IE	Health Products Regulatory Authority	Identifier(s): 88486, 88490
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6700, 7040
Country: IT	Agenzia del Farmaco	Identifier(s): 038328011, 038328023, 038328035, 038328047, 038328050, 038328062, 038328074, 038328086, 038328098, 038328100, 038328112, 038328124, 038328136, 038328148, 038328151
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291021M1020, 4291021M2027, 4291021M3023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031006, 1031007, 1031008, 1031009, 1058052, 1058053, 1064319, 1064320, 1064321, 1064322, 1064323, 1064324, 1080835, 1080836, 1084546
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 227M2008
Country: NG	Registered Drug Product Database	Identifier(s): A4-3031
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 87017, 95761
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13028, 14479
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100025853, 100238678, 100396590
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64606001, W64606002, W64607001, W64608001
Country: SG	Health Sciences Authority	Identifier(s): 13498P, 13959P, 15837P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10283271H, 10283272H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699504150605, 8699504150704, 8699504150957, 8699504150964
Country: US	FDA, National Drug Code	Identifier(s): 0078-0526, 0078-0592, 0078-0951
Country: ZA	Health Products Regulatory Authority	Identifier(s): 41/26/0973, 45/26/0410