TEVA-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIMETHYL FUMARATE

Available from:

TEVA CANADA LIMITED

ATC code:

L04AX07

INN (International Name):

DIMETHYL FUMARATE

Dosage:

240MG

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

DIMETHYL FUMARATE 240MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-10-04

Summary of Product characteristics

_Teva-Dimethyl Fumarate _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, Oral
Antineoplastic and Immunomodulating Agents
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
October 30, 2019
Date of Revision:
July 29, 2022
Submission Control No: 261462
_Teva-Dimethyl Fumarate _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2022
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
Pediatrics
......................................................................................................
4
1.2
Geriatrics
......................................................................................................
4
2
CONTRAINDICATIONS......................................................................................................4
4
DOSAGE AND ADMINISTRATION
.......................................................................................4
4.1
Dosing
Considerations.....................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.4
Administration
...............................................................................................
5
4.5
Missed Dose
................................................................