MAYZENT TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SIPONIMOD

Доступна з:

NOVARTIS PHARMACEUTICALS CANADA INC

Код атс:

L04AE03

ІПН (Міжнародна Ім'я):

SIPONIMOD

Дозування:

2MG

Фармацевтична форма:

TABLET

Склад:

SIPONIMOD 2MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

Immunomodulatory Agents

Огляд продуктів:

Active ingredient group (AIG) number: 0162037002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2020-02-20

Характеристики продукта

_MAYZENT_
_®_
_ (siponimod) _
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAYZENT®
Siponimod tablets
Film coated tablets, 0.25 mg, 1 mg and 2 mg siponimod, oral
Sphingosine 1-phosphate receptor modulator
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec
H2Y 0C1
Date of Initial Authorization:
February 20, 2020
Date of Revision:
November 20, 2023
Submission Control Number: 273930
MAYZENT is a registered trademark
_ _
_MAYZENT_
_®_
_ (siponimod) _
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
11/2023
7 Warnings and Precautions, Neoplasm
08/2022
7 Warnings and Precautions, Immune, Risk of Infections
02/2023
7 Warnings and Precautions, Endocrine and Metabolism -
Pharmacogenomics
06/2023
7 Warnings and precautions, Immune - Vaccination
06/2023
7 Warnings and Precautions, Immune
06/2023
7 Warnings and Precautions, Neurologic
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
.........................................................................................