GAVRETO CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRALSETINIB

Διαθέσιμο από:

HOFFMANN-LA ROCHE LIMITED

Φαρμακολογική κατηγορία (ATC):

L01EX23

INN (Διεθνής Όνομα):

PRALSETINIB

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

PRALSETINIB 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-06-30

Αρχείο Π.Χ.Π.

_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