PMS-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DIMETHYL FUMARATE

Предлага се от:

PHARMASCIENCE INC

АТС код:

L04AX07

INN (Международно Name):

DIMETHYL FUMARATE

дозиране:

240MG

Лекарствена форма:

CAPSULE (DELAYED RELEASE)

Композиция:

DIMETHYL FUMARATE 240MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0154210002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2021-10-04

Данни за 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
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4
2
CONTRAINDICATIONS
........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................