APO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-01-2023
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Active ingredient:
DIMETHYL FUMARATE
Available from:
APOTEX INC
ATC code:
L04AX07
INN (International Name):
DIMETHYL FUMARATE
Dosage:
240MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DIMETHYL FUMARATE 240MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Product summary:
Active ingredient group (AIG) number: 0154210002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-10-04
Summary of Product characteristics
_APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, Oral
Antineoplastic and Immunomodulating Agents
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 04, 2021
Date of Revision:
January 11, 2023
Submission Control Number: 266551
_APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
01/2023
2 CONTRAINDICATIONS
01/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
01/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
7 WARNINGS AND PRECAUTIONS, Immune
01/2023
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
.................................................................................................4
4.
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