AURO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DIMETHYL FUMARATE

Prieinama:

AURO PHARMA INC

ATC kodas:

L04AX07

INN (Tarptautinis Pavadinimas):

DIMETHYL FUMARATE

Dozė:

240MG

Vaisto forma:

CAPSULE (DELAYED RELEASE)

Sudėtis:

DIMETHYL FUMARATE 240MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Produkto santrauka:

Active ingredient group (AIG) number: 0154210002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2023-08-28

Prekės savybės

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
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4
1.2
Geriatrics........................................................................................................................
4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
...................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
............................................................... 5
4.4 Administration
......................................................