Country: Canada
Language: English
Source: Health Canada
ANASTROZOLE
MINT PHARMACEUTICALS INC
L02BG03
ANASTROZOLE
1MG
TABLET
ANASTROZOLE 1MG
ORAL
30
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0128681001; AHFS:
APPROVED
2013-11-25
_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 .................................................................. Read the complete document