LETROZOLE SUN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LETROZOLE

Предлага се от:

TARO 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:

14

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2022-07-11

Данни за продукта

PRODUCT MONOGRAPH
PR
LETROZOLE SUN
Letrozole Tablets
2.5 mg
Manufacturer’s Standard
Non-steroidal aromatase inhibitor; inhibitor of estrogen biosynthesis;
anti-tumour agent
Taro Pharmaceuticals Inc. DATE OF REVISION
: June 24, 2019
130 East Drive
Brampton, Ontario
L6T 1C1
SUBMISSION CONTROL NO: 228379
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
..........................................................................31
CLINICAL TRIALS
..........................................................................................................32
DETAILED PHARMACOLOGY
...............................