ROZLYTREK

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

Active ingredients

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

1 Entrectinib UNII L5ORF0AN1I - ENTRECTINIB

Entrectinib is an inhibitor of the tropomyosin receptor tyrosine kinases TRKA, TRKB and TRKC (encoded by the neurotrophic tyrosine receptor kinase [NTRK] genes NTRK1, NTRK2 and NTRK3, respectively), proto-oncogene tyrosine-protein kinase ROS (ROS1), and anaplastic lymphoma kinase (ALK). Entrectinib demonstrated in vitro and in vivo inhibition of cancer cell lines derived from multiple tumour types, including subcutaneous and intracranial tumours, harbouring NTRK, ROS1, and ALK fusion genes. Read about Entrectinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ROZLYTREK Σκληρό καψάκιο	European Medicines Agency (EU)	MPI, EU: SmPC
ROZLYTREK Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC
ROZLYTREK Hard capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
L01EX14		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX14

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): 12092K
Country: CA	Health Products and Food Branch	Identifier(s): 02495007, 02495015
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 6202-MEE-0421, 6240-MEE-0521
Country: EE	Ravimiamet	Identifier(s): 1824410, 1824421
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 494076, 592172
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 388274, 388278
Country: HK	Department of Health Drug Office	Identifier(s): 66639, 66640
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8532, 8533
Country: IT	Agenzia del Farmaco	Identifier(s): 048961015, 048961027
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291061M1025, 4291061M2021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1090964, 1090965
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 204617, 204625
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20803, 20804
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100439030, 100439046
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66908001, W66909001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505152882, 8699505153032
Country: US	FDA, National Drug Code	Identifier(s): 50242-091, 50242-094