JAMP DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DIMETHYL FUMARATE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

L04AX07

INN (Nama Internasional):

DIMETHYL FUMARATE

Dosis:

120MG

Bentuk farmasi:

CAPSULE (DELAYED RELEASE)

Komposisi:

DIMETHYL FUMARATE 120MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-10-04

Karakteristik produk

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JAMP DIMETHYL FUMARATE
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_(dimethyl fumarate delayed-release capsules)_ Page 1 of 43
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
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JAMP DIMETHYL FUMARATE
Dimethyl fumarate delayed-release capsules
Delayed-release capsules, 120 mg and 240 mg, oral
Antineoplastic and Immunomodulating Agents
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 04, 2021
Date of Revision:
January 9, 2024
Submission Control Number: 277583
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JAMP DIMETHYL FUMARATE
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_(dimethyl fumarate delayed-release capsules)_ Page 2 of 43
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION.....................................................................
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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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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