AURO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
22-08-2023
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Ingredient activ:
DIMETHYL FUMARATE
Disponibil de la:
AURO PHARMA INC
Codul ATC:
L04AX07
INN (nume internaţional):
DIMETHYL FUMARATE
Dozare:
240MG
Forma farmaceutică:
CAPSULE (DELAYED RELEASE)
Compoziție:
DIMETHYL FUMARATE 240MG
Calea de administrare:
ORAL
Unități în pachet:
100
Tip de prescriptie medicala:
Prescription
Rezumat produs:
Active ingredient group (AIG) number: 0154210002; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2023-08-28
Caracteristicilor produsului
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
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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
......................................................
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