MINT-LETROZOLE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LETROZOLE

Предлага се от:

MINT PHARMACEUTICALS INC

АТС код:

L02BG04

INN (Международно Name):

LETROZOLE

дозиране:

2.5MG

Лекарствена форма:

TABLET

Композиция:

LETROZOLE 2.5MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-11-20

Данни за продукта

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
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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
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5
4.1.
Dosing Considerations
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5
4.2.
Recommended Dose and Dosage Adjustment
............................................................... 5
4.4.
Administration
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6
4.5.
Missed Dose
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6
5.
OVERDOSAGE
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