IPG-ANASTROZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANASTROZOLE

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

L02BG03

INN (International Name):

ANASTROZOLE

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

ANASTROZOLE 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2016-03-21

Summary of Product characteristics

Page 1 of 59
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IPG-ANASTROZOLE
Anastrozole tablets
Tablet 1 mg, Oral use
USP
Non-Steroidal Aromatase Inhibitor
Marcan Pharmaceuticals Inc.
2 Gurdwara Rd. Suite# 112
Ottawa, Ontario K2E 1A2
www.marcanpharma.com
Date of Initial Authorization:
SEP 28, 2011
Date of Revision:
MAR 15, 2023
Submission Control Number: 271578
Page 2 of 59
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................................................................
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
...............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.4
Administration.....................................................................................................
5
4.5
Missed
Dose.......................................................................................................
5
5
OVERDOSAGE
...........................................................