TEVA-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DIMETHYL FUMARATE

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

L04AX07

INN (International Adı):

DIMETHYL FUMARATE

Doz:

240MG

Farmasötik formu:

CAPSULE (DELAYED RELEASE)

Kompozisyon:

DIMETHYL FUMARATE 240MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2021-10-04

Ürün özellikleri

_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
................................................................