MAR-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DIMETHYL FUMARATE

Tersedia dari:

MARCAN PHARMACEUTICALS INC

Kode ATC:

L04AX07

INN (Nama Internasional):

DIMETHYL FUMARATE

Dosis:

120MG

Bentuk farmasi:

CAPSULE (DELAYED RELEASE)

Komposisi:

DIMETHYL FUMARATE 120MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-10-04

Karakteristik produk

_MAR-DIMETHYL FUMARATE PM_
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_Page 1 of 34_
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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_
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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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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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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