Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
DIMETHYL FUMARATE
SANDOZ CANADA INCORPORATED
L04AX07
DIMETHYL FUMARATE
120MG
CAPSULE (DELAYED RELEASE)
DIMETHYL FUMARATE 120MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0154210001; AHFS:
APPROVED
2021-10-04
_Sandoz Dimethyl Fumarate _ _Page 1 of 46 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOZ DIMETHYL FUMARATE dimethyl fumarate delayed-release capsules delayed-release capsules, 120 mg and 240 mg, oral Antineoplastic and Immunomodulating Agents Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, (Québec), Canada J4B 1E6 Date of Initial Authorization: October 4, 2021 Date of Revision: May 19, 2022 Submission Control Number: 259700 _Sandoz Dimethyl Fumarate _ _Page 2 of 46 _ 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, Hematologic 05/2022 7 WARNINGS AND PRECAUTIONS, Immune 05/2022 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 P EDIATRICS .......................................................................................................................... 4 1.2 G ERIATRICS .......................................................................................................................... 4 2 CONTRAINDICATIONS.......................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ........................................................................................... 5 4.1 D OSING C ONSIDERATI ONS .............................................................................................. Soma hati kamili