SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES CAPSULE (DELAYED RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DIMETHYL FUMARATE

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

L04AX07

INN (שם בינלאומי):

DIMETHYL FUMARATE

כמות:

240MG

טופס פרצבטיות:

CAPSULE (DELAYED RELEASE)

הרכב:

DIMETHYL FUMARATE 240MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2021-10-04

מאפייני מוצר

_Sandoz Dimethyl Fumarate Delayed-Release Capsules _
_ _
_Page 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES
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, QC, J4B 1E6
Canada
Submission Control No: 280774
Date of
Initial Authorization:
OCT
04, 2021
Date of Revision:
DEC
06, 2023
_Sandoz Dimethyl Fumarate Delayed-Release Capsules _
_ _
_Page 2 of 46 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
12/2023
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data
12/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
12/2023
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
....................................................................................
5
4.1 Dosing Considerations
..............................................................................................
5
4.2