LETROZOLE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LETROZOLE

から入手可能:

TEVA CANADA LIMITED

ATCコード:

L02BG04

INN（国際名）:

LETROZOLE

投薬量:

2.5MG

医薬品形態:

TABLET

構図:

LETROZOLE 2.5MG

投与経路:

ORAL

パッケージ内のユニット:

28/30

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0132937001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2013-12-10

製品の特徴

PRODUCT MONOGRAPH
PR
LETROZOLE
(letrozole)
LETROZOLE TABLETS, USP
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
antitumour agent
LETROZOLE (letrozole) indicated for:
•
The adjuvant treatment of postmenopausal women with hormone
receptor-positive early
breast cancer;
•
The extended adjuvant treatment of hormone receptor-positive early
breast cancer in
postmenopausal women who have received approximately 5 years of prior
standard
adjuvant tamoxifen therapy;
has been issued market authorization with conditions, pending the
results of studies to verify its
clinical benefit. Patients should be advised of the nature of the
market authorization granted.
LETROZOLE, indicated for:
•
The first-line therapy in postmenopausal women with advanced breast
cancer;
•
The hormonal treatment of advanced/metastatic breast cancer in women
with natural or
artificially-induced postmenopausal status, who have disease
progression following
antiestrogen therapy;
has been issued market authorisation without conditions.
LETROZOLE should be administered under the supervision of a qualified
physician experienced
in the use of anti-cancer agents.
Teva Canada Limited
DATE OF REVISION:
30 Novopharm Court
February 10, 2010
Toronto, Ontario
M1B 2K9
SUBMISSION CONTROL NO: 137039
_Page 2 _
THIS PRODUCT HAS BEEN APPROVED UNDER THE
NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)
POLICY FOR ONE OR ALL OF ITS INDICATED USES.
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
approved
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