MAR-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DIMETHYL FUMARATE

Доступно од:

MARCAN PHARMACEUTICALS INC

АТЦ код:

L04AX07

INN (Међународно име):

DIMETHYL FUMARATE

Дозирање:

120MG

Фармацеутски облик:

CAPSULE (DELAYED RELEASE)

Састав:

DIMETHYL FUMARATE 120MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2021-10-04

Карактеристике производа

_MAR-DIMETHYL FUMARATE PM_
_ _
_ _
_Page 1 of 34_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-DIMETHYL FUMARATE
dimethyl fumarate delayed release capsules
delayed-release capsules, 120 mg and 240 mg, oral
Antineoplastic and Immunomodulating Agents
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite 112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
OCT 04, 2021
Date of Revision:
NOV 01, 2023
Submission Control Number: 277607
_MAR-DIMETHYL FUMARATE PM _
_Page 2 of 38_
_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
05/2022
2 CONTRAINDICATIONS
05/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
05/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
11/2023
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data
11/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
11/2023
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
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
........................................................................