PMS-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

DIMETHYL FUMARATE

Доступна з:

PHARMASCIENCE INC

Код атс:

L04AX07

ІПН (Міжнародна Ім'я):

DIMETHYL FUMARATE

Дозування:

120MG

Фармацевтична форма:

CAPSULE (DELAYED RELEASE)

Склад:

DIMETHYL FUMARATE 120MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0154210001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2021-10-04

Характеристики продукта

_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, for Oral Use
House Standard
Antineoplastic and Immunomodulating Agents
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Initial Authorization:
OCT 4, 2021
Date of Revision:
NOV 8, 2023
www.pharmascience.com
Submission Control Number: 277364
_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
06/2022
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings: Hematologic,
Clinical
Chemistry and Other Quantitative Data
05/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
05/2023
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
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
....................................................