PMS-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DIMETHYL FUMARATE

MAH:

PHARMASCIENCE INC

ATC_code:

L04AX07

INN:

DIMETHYL FUMARATE

dosage:

120MG

pharmaceutical_form:

CAPSULE (DELAYED RELEASE)

composition:

DIMETHYL FUMARATE 120MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2021-10-04

SPC

_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
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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
....................................................