AURO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-08-2023
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Active ingredient:
DIMETHYL FUMARATE
Available from:
AURO PHARMA INC
ATC code:
L04AX07
INN (International Name):
DIMETHYL FUMARATE
Dosage:
120MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DIMETHYL FUMARATE 120MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0154210001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-08-28
Summary of Product characteristics
AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules)
Page 1 of 43
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AURO-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, Oral
House Standard
Antineoplastic and Immunomodulating Agents
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
August 22, 2023
Submission Control Number: 269223
AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules)
Page 2 of 43
RECENT MAJOR LABEL CHANGES
Not Applicable
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
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
.......................................................................................................................
4
1.2
Geriatrics........................................................................................................................
4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
........................................................................................
4
4.1 Dosing Considerations
...................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
............................................................... 5
4.4 Administration
......................................................
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