Land: Canada
Sprog: engelsk
Kilde: Health Canada
DIMETHYL FUMARATE
MARCAN PHARMACEUTICALS INC
L04AX07
DIMETHYL FUMARATE
240MG
CAPSULE (DELAYED RELEASE)
DIMETHYL FUMARATE 240MG
ORAL
15G/50G
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0154210002; AHFS:
APPROVED
2021-10-04
_MAR-DIMETHYL FUMARATE PM_ _ _ _ _ _Page 1 of 34_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MAR-DIMETHYL FUMARATE dimethyl fumarate delayed release capsules delayed-release capsules, 120 mg and 240 mg, oral Antineoplastic and Immunomodulating Agents Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite 112 Ottawa, ON K2E 1A2 Date of Initial Authorization: OCT 04, 2021 Date of Revision: NOV 01, 2023 Submission Control Number: 277607 _MAR-DIMETHYL FUMARATE PM _ _Page 2 of 38_ _ _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 05/2022 2 CONTRAINDICATIONS 05/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 05/2022 7 WARNINGS AND PRECAUTIONS, Immune 05/2022 7 WARNINGS AND PRECAUTIONS, Hematologic 11/2023 8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data 11/2023 10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics 11/2023 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 ........................................................................ Læs hele dokumentet