ZYKADIA CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CERITINIB

から入手可能:

NOVARTIS PHARMACEUTICALS CANADA INC

ATCコード:

L01ED02

INN（国際名）:

CERITINIB

投薬量:

150MG

医薬品形態:

CAPSULE

構図:

CERITINIB 150MG

投与経路:

ORAL

パッケージ内のユニット:

150

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0156510001; AHFS:

認証ステータス:

APPROVED

承認日:

2015-03-27

製品の特徴

_ZYKADIA_
_®_
_ (ceritinib) Product Monograph _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZYKADIA®
Ceritinib Capsules
Capsules, 150 mg, Oral
Protein Kinase Inhibitor (L01XE)
ZYKADIA (ceritinib) as monotherapy, indicated for:
- the treatment of adult patients with anaplastic lymphoma kinase
(ALK)-positive locally advanced
(not amenable to curative therapy) or metastatic non-small cell lung
cancer (NSCLC) who have
progressed on or who were intolerant to crizotinib,
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 ZYKADIA 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.
ZYKADIA as monotherapy, indicated for:
- the first-line treatment of adult patients with ALK-positive locally
advanced (not amenable to
curative therapy) or metastatic NSCLC,
has been issued market authorization without conditions.
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
Mar 27, 2015
Date of Revision:
Feb 25, 2022
Submission Control Number: 250707
ZYKADIA is a registered trademark.
_ _
_ZYKADIA_
_®_
_ (ceritinib) Product Monograph _
_Page 2 of 63_
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