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:

ACTAVIS PHARMA COMPANY

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:

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:

2018-06-18

製品の特徴

_Page 1 of 60 _
PRODUCT MONOGRAPH
PR LETROZOLE
(letrozole tablets USP)
2.5 mg
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
DATE OF PREPARATION:
October 30, 2014
SUBMISSION CONTROL N
o: 178801
_Page 2 of 60 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
........................................................................................................
9
DRUG INTERACTIONS
.......................................................................................................
24
DOSAGE AND ADMINISTRATION
...................................................................................
26
OVERDOSAGE
.....................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 27
STORAGE AND STABILITY
..............................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 30
PART II: SCIENTIFIC INFORMATION
.............................................................. 31
PHARMACEUTICAL INFORMATION
..............................................................................
31
CLINICAL TRIALS
.....................................................................................................