AURO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
22-08-2023
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DIMETHYL FUMARATE
Fáanlegur frá:
AURO PHARMA INC
ATC númer:
L04AX07
INN (Alþjóðlegt nafn):
DIMETHYL FUMARATE
Skammtar:
240MG
Lyfjaform:
CAPSULE (DELAYED RELEASE)
Samsetning:
DIMETHYL FUMARATE 240MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0154210002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-08-28
Vara einkenni
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
.............................................................................................................
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
4.1 Dosing Considerations
...................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
............................................................... 5
4.4 Administration
......................................................
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