TEVA-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:

30/100/500

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:

APPROVED

承認日:

2013-05-07

製品の特徴

_TEVA-LETROZOLE (Letrozole Tablets) _
_ Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-LETROZOLE
Letrozole Tablets
Tablets, 2.5 mg, Oral
Teva Standard
Aromatase inhibitor
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
April 28, 2010
Toronto, ON
M1B 2K9
Date of Revision:
Canada
July 26, 2023
www.tevacanada.com
Submission Control Number: 272279
_TEVA-LETROZOLE (Letrozole Tablets) Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
07/2023
TABLE OF CONTENTS
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
..............................................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
..........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................... 5
4.4
Administration
....................................................................................................