Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ENTRECTINIB
HOFFMANN-LA ROCHE LIMITED
L01EX14
ENTRECTINIB
100MG
CAPSULE
ENTRECTINIB 100MG
ORAL
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0162010001; AHFS:
APPROVED
2020-02-10
_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 Přečtěte si celý dokument