TEVA-ANASTROZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANASTROZOLE

Available from:

TEVA CANADA LIMITED

ATC code:

L02BG03

INN (International Name):

ANASTROZOLE

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

ANASTROZOLE 1MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-12-01

Summary of Product characteristics

TEVA-ANASTROZOLE
Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ANASTROZOLE
Anastrozole Tablets
Tablet, 1 mg, Oral
Teva Standard
Non-Steroidal Aromatase Inhibitor (L02BG03)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
October 25, 2012
Date of Revision:
March 16, 2023
Submission Control Number: 271296
TEVA-ANASTROZOLE
Page 2 of 68
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
03/2023
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………………………………………………………………………5
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
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
............................................................................................................
5
4.5
Missed Dose
..............................................................