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

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DIMETHYL FUMARATE

Prieinama:

SANDOZ CANADA INCORPORATED

ATC kodas:

L04AX07

INN (Tarptautinis Pavadinimas):

DIMETHYL FUMARATE

Dozė:

240MG

Vaisto forma:

CAPSULE (DELAYED RELEASE)

Sudėtis:

DIMETHYL FUMARATE 240MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2021-10-04

Prekės savybės

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2