Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
DIMETHYL FUMARATE
APOTEX INC
L04AX07
DIMETHYL FUMARATE
120MG
CAPSULE (DELAYED RELEASE)
DIMETHYL FUMARATE 120MG
ORAL
15G/50G
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0154210001; AHFS:
APPROVED
2021-10-04
_APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _ _Page 1 of 37 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-DIMETHYL FUMARATE Dimethyl Fumarate Delayed-Release Capsules Delayed-Release Capsules, 120 mg and 240 mg, Oral Antineoplastic and Immunomodulating Agents Apotex Inc. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: October 04, 2021 Date of Revision: January 11, 2023 Submission Control Number: 266551 _APO-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _ _Page 2 of 37 _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 01/2023 2 CONTRAINDICATIONS 01/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2023 7 WARNINGS AND PRECAUTIONS, Hematologic 01/2023 7 WARNINGS AND PRECAUTIONS, Immune 01/2023 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 .................................................................................................4 4. Izlasiet visu dokumentu