APO-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DIMETHYL FUMARATE

Tilgængelig fra:

APOTEX INC

ATC-kode:

L04AX07

INN (International Name):

DIMETHYL FUMARATE

Dosering:

240MG

Lægemiddelform:

CAPSULE (DELAYED RELEASE)

Sammensætning:

DIMETHYL FUMARATE 240MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-10-04

Produktets egenskaber

_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.