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

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DIMETHYL FUMARATE

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

L04AX07

INN (International Name):

DIMETHYL FUMARATE

Dosering:

120MG

Lægemiddelform:

CAPSULE (DELAYED RELEASE)

Sammensætning:

DIMETHYL FUMARATE 120MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0154210001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-10-04

Produktets egenskaber

_Sandoz Dimethyl Fumarate Delayed-Release Capsules _
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_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
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1 Dosing Considerations
..............................................................................................
5
4.2