VOTRIENT TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Предлага се от:

NOVARTIS PHARMACEUTICALS CANADA INC

АТС код:

L01EX03

INN (Международно Name):

PAZOPANIB

дозиране:

400MG

Лекарствена форма:

TABLET

Композиция:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 400MG

Начин на приложение:

ORAL

Броя в опаковка:

30/60

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0152743002; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2020-07-08

Данни за продукта

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_Page 1 of 53 _
PRODUCT MONOGRAPH
PR VOTRIENT
®
Pazopanib (as pazopanib hydrochloride)
Tablets, 200 mg and 400 mg
Antineoplastic Agent
Submission Control No: 234074
VOTRIENT is a registered trademark
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Revision:
February 28, 2020
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_Page 2 of 53 _
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
..........................................................................................
15
DRUG INTERACTIONS
..........................................................................................
24
DOSAGE AND ADMINISTRATION
.........................................................................
28
OVERDOSAGE
.......................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 30
STORAGE AND STABILITY
...................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..........................................................................
34
PHARMACEUTICAL INFORMATION
.....................................................................
34
CLINICAL TRIALS
.................................................................................................
34
DETAILED PHARMACOLOGY
.........................................................