GLN-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DIMETHYL FUMARATE

Доступно од:

GLENMARK PHARMACEUTICALS CANADA INC.

АТЦ код:

L04AX07

INN (Међународно име):

DIMETHYL FUMARATE

Дозирање:

240MG

Фармацеутски облик:

CAPSULE (DELAYED RELEASE)

Састав:

DIMETHYL FUMARATE 240MG

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: 0154210002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2021-10-04

Карактеристике производа

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_GLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) _
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_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-DIMETHYL FUMARATE
dimethyl fumarate delayed-release capsules
delayed-release capsules, 120 mg and 240 mg, oral
Antineoplastic and Immunomodulating Agents
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, ON
L4K 4M2
Date of Initial Authorization:
October 04, 2021
Date of Revision:
November 2, 2023
Submission Control No: 277311
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_GLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) _
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_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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