ROZLYTREK

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

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 more about Entrectinib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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