JAKAVI TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

RUXOLITINIB (RUXOLITINIB PHOSPHATE)

Доступна з:

NOVARTIS PHARMACEUTICALS CANADA INC

Код атс:

L01EJ01

ІПН (Міжнародна Ім'я):

RUXOLITINIB

Дозування:

15MG

Фармацевтична форма:

TABLET

Склад:

RUXOLITINIB (RUXOLITINIB PHOSPHATE) 15MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

56/60

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0153186003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2012-06-19

Характеристики продукта

_JAKAVI_
®
_ ruxolitinib (as ruxolitinib phosphate) _
_Page 1 of 77_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAKAVI
®
Ruxolitinib tablets
Tablets, 5 mg, 10 mg, 15 mg and 20 mg ruxolitinib (as ruxolitinib
phosphate), oral
Antineoplastic agent
Novartis Pharmaceuticals Canada Inc.
700, rue Saint-Hubert, bureau 100
Montreal, Quebec,
H2Y 0C1
www.novartis.ca
Date of Initial Authorization:
Jun 15, 2012
Date of Revision:
Apr 28, 2023
Submission Control Number: 269250
_JAKAVI is a registered trademark_
_ _
_JAKAVI_
®
_ ruxolitinib (as ruxolitinib phosphate) _
_Page 2 of 77_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
05/2022
1 INDICATIONS, 1.1 Pediatrics
05/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
05/2022
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
05/2022
7 WARNING AND PRECAUTIONS, Carcinogenesis and Mutagenesis
04/2023
7 WARNING AND PRECAUTIONS, Cardiovascular
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
05/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES ...........................................................................................
2
TABLE OF CONTENTS .............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...................................................................................................
4
1.1
Pediatrics
..............................................................................................................
4
1.2
Geriatrics
..............................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................