MINT-LETROZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LETROZOLE

Available from:

MINT PHARMACEUTICALS INC

ATC code:

L02BG04

INN (International Name):

LETROZOLE

Dosage:

2.5MG

Pharmaceutical form:

TABLET

Composition:

LETROZOLE 2.5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132937001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-11-20

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Date of Initial Authorization:
NOV 20, 2020
Date of Revision:
MAR 07, 2024
Submission Control Number: 279174
Mint-Letrozole _(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
03/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1.
INDICATIONS
...............................................................................................................
4
1.1.
Paediatrics
.......................................................................................................................
4
1.2.
Geriatrics
.........................................................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................................
4
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
................................................................................................................
6
4.5.
Missed Dose
....................................................................................................................
6
5.
OVERDOSAGE
..............................................................