GAVRETO CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PRALSETINIB

Disponible des:

HOFFMANN-LA ROCHE LIMITED

Codi ATC:

L01EX23

Designació comuna internacional (DCI):

PRALSETINIB

Dosis:

100MG

formulario farmacéutico:

CAPSULE

Composición:

PRALSETINIB 100MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0163030001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-06-30

Fitxa tècnica

_Pr_
_GAVRETO™(pralsetinib) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GAVRETO™
pralsetinib capsules
Capsules, 100 mg pralsetinib, Oral
Protein Kinase Inhibitor (L01EX)
GAVRETO, indicated for:

the treatment of adult patients with rearranged during transfection
(_RET_) fusion-positive locally
advanced unresectable or metastatic non-small cell lung cancer
(NSCLC).
has been issued market authorization with conditions, pending the
results of trials to verify its clinical
benefit. Patients should be advised of the nature of the
authorization. For further information for
GAVRETO please refer to Health Canada’s Notice of Compliance with
conditions - drug products web
site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-
compliance/conditions.html”
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
Date of Initial Authorization:
June 30, 2021
Submission Control Number: 243731
GAVRETO™ is a trade-mark of Blueprint Medicines Corporation, used
under license.
©
Copyright 2021, Hoffmann-La Roche Limited
_ _
_Pr_
_GAVRETO™(pralsetinib) _
_Page 2 of 40_
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
_An 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 in Canada or have demonstrated a significant improvement in the
benefit/risk profile over _
_existing therapies. Health Canada has provided access to this product
on the condition that _
_sponsors carry out additional clinical trial