GILENYA CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Доступна з:

NOVARTIS PHARMACEUTICALS CANADA INC

Код атс:

L04AE01

ІПН (Міжнародна Ім'я):

FINGOLIMOD

Дозування:

0.25MG

Фармацевтична форма:

CAPSULE

Склад:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.25MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

28

Тип рецепту:

Prescription

Терапевтична области:

Immunomodulatory Agents

Огляд продуктів:

Active ingredient group (AIG) number: 0152886002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-11-07

Характеристики продукта

_GILENYA_
_®_
_ (fingolimod as fingolimod hydrochloride) _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GILENYA®
Fingolimod capsules
Capsule, 0.25 mg and 0.5 mg (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Authorization:
MAR 09, 2011
Date of Revision:
JUL 26, 2021
Submission Control Number: 249522
GILENYA is a registered trademark
_GILENYA_
_®_
_ (fingolimod as fingolimod hydrochloride) _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
2 Contraindications
10/ 2019
4 Dosage and Administration
07/ 2021
7 Warnings and Precautions
07/ 2021
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
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 7
4.4
Administration..................................