DOM-BICALUTAMIDE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

BICALUTAMIDE

Предлага се от:

DOMINION PHARMACAL

АТС код:

L02BB03

INN (Международно Name):

BICALUTAMIDE

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

BICALUTAMIDE 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0127996001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2006-06-16

Данни за продукта

PRODUCT MONOGRAPH
PR
DOM-BICALUTAMIDE
Bicalutamide Tablets, House Standard
50 mg
NON-STEROIDAL ANTIANDROGEN
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
March 15, 2017
Submission Control No.: 202528
_ _
_Dom-BICALUTAMIDE Product Monograph _
_ _
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.............................................