TAGRISSO

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

Active ingredients

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

1	Osimertinib UNII RDL94R2A16 - OSIMERTINIB MESYLATE
	Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of EGFRs harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M. In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant NSCLC cell lines.
	Read more about Osimertinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TAGRISSO Film-coated tablet	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
L01EB04		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
Discover more medicines within L01EB04

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	11620N, 11622Q, 12232T, 12233W
BR	Câmara de Regulação do Mercado de Medicamentos	502317030030901, 502317030031001
CA	Health Products and Food Branch	02456214, 02456222
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	4376-MEE-0918, 4377-MEE-0918
EE	Ravimiamet	1710379, 1710380, 1711538, 1734858, 1734869
ES	Centro de información online de medicamentos de la AEMPS	1161086001, 1161086002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	412918, 510600
FR	Base de données publique des médicaments	60368512, 60463095
GB	Medicines & Healthcare Products Regulatory Agency	327010, 327016, 392549, 392551
HK	Department of Health Drug Office	64834, 64835
IE	Health Products Regulatory Authority	89022, 89023
IL	מִשְׂרַד הַבְּרִיאוּת	7840, 8353
IT	Agenzia del Farmaco	044729010, 044729022, 044729034, 044729046
JP	医薬品医療機器総合機構	4291045F1027, 4291045F2023
LT	Valstybinė vaistų kontrolės tarnyba	1079653, 1079654, 1081294, 1081295
NG	Registered Drug Product Database	A4-100098, A4-100099
Switch country to Nigeria in order to find specific presentations of TAGRISSO
NL	Z-Index G-Standaard, PRK	130575, 130583
NZ	Medicines and Medical Devices Safety Authority	18617, 18618
PL	Rejestru Produktów Leczniczych	100364800, 100364816
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W62648001, W62648002, W62649001, W62649002
SG	Health Sciences Authority	15139P, 15140P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699786092860, 8699786092877
US	FDA, National Drug Code	0310-1349, 0310-1350
ZA	Health Products Regulatory Authority	51/26/0927, 51/26/0928