ROZLYTREK CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ENTRECTINIB

Tersedia dari:

HOFFMANN-LA ROCHE LIMITED

Kode ATC:

L01EX14

INN (Nama Internasional):

ENTRECTINIB

Dosis:

100MG

Bentuk farmasi:

CAPSULE

Komposisi:

ENTRECTINIB 100MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0162010001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-02-10

Karakteristik produk

_ROZLYTREK_
®
_ (entrectinib) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ROZLYTREK
®
entrectinib capsules
Capsules, 100 mg and 200 mg, Oral
Antineoplastic agent
_ROZLYTREK, indicated for: _
_ _
_- the treatment of adult patients with unresectable locally advanced
or metastatic _
_extracranial solid tumours, including brain metastases, that have a
neurotrophic tyrosine _
_receptor kinase (NTRK) gene fusion without a known acquired
resistance mutation, and with _
_no satisfactory treatment options _
_has been issued marketing authorization with conditions, pending the
results of new _
_information to verify its clinical benefit. Patients should be
advised of the nature of the _
_authorization. For further information for ROZLYTREK please refer to
Health Canada’s Notice _
_of Compliance with conditions - drug products web site. _
_ROZLYTREK, indicated for: _
_- the treatment of patients with ROS1-positive, locally advanced or
metastatic non-small cell _
_lung cancer (NSCLC) _
_has been issued market authorization without conditions. _
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, ON L5N 5M8
Date of Initial Authorization:
FEB 07, 2020
Date of Revision:
NOV 09, 2023
Submission Control No: 271291
ROZLYTREK
®
is a trademark of F. Hoffmann-La Roche AG, used under license
©
Copyright 2023, Hoffmann-La Roche Limited
_ _
_ROZLYTREK_
®
_ (entrectinib) _
_Page 2 of 46_
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
A NOC/c is a form of market approval granted to a product on the basis
of promising evidence
of clinical effectiveness following review of the submission by Health
Canada.
Products authorized under Health Canada’s NOC/c policy are intended
for the treatment,
prevention or diagnosis of a serious, life-threatening or severely
debilitating illness. They have
demonstrated promising benefit, are of high quality and possess an
acceptable safety profile
based on a benefit/risk assessment. In addition, they either respond
to a serious unmet medical
need i