MINT-LETROZOLE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LETROZOLE

MAH:

MINT PHARMACEUTICALS INC

ATC_code:

L02BG04

INN:

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

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2020-11-20

SPC

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1.
INDICATIONS
...............................................................................................................
4
1.1.
Paediatrics
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4
1.2.
Geriatrics
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4
2.
CONTRAINDICATIONS
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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
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