TASIGNA

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

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 more about Nilotinib

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-3031	Capsule	Tasigna 200 mg Capsules CAP 200 mg	Each capsule contains: Nilotinib Base (as Hydrochloride, Monohydrate) 200 mg	28/05/2021

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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