TAGRISSO

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

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 about Osimertinib

Medication package inserts

Below package inserts are available for further reading:

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