MINT-ANASTROZOLE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ANASTROZOLE

제공처:

MINT PHARMACEUTICALS INC

ATC 코드:

L02BG03

INN (국제 이름):

ANASTROZOLE

복용량:

1MG

약제 형태:

TABLET

구성:

ANASTROZOLE 1MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0128681001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-11-25

제품 특성 요약

_MINT-ANASTROZOLE_
_® _
_Product Monograph _
_Page 1 of 55_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ANASTROZOLE
Anastrozole tablets
Tablet 1 mg, Oral use
USP
Non-Steroidal Aromatase Inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
NOV 22, 2013
Date of Revision:
AUG 1, 2023
Submission Control Number: 275056
_MINT-ANASTROZOLE_
_® _
_Product Monograph _
_Page 2 of 55_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
..................................................................