JAMP DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DIMETHYL FUMARATE

Disponible depuis:

JAMP PHARMA CORPORATION

Code ATC:

L04AX07

DCI (Dénomination commune internationale):

DIMETHYL FUMARATE

Dosage:

120MG

forme pharmaceutique:

CAPSULE (DELAYED RELEASE)

Composition:

DIMETHYL FUMARATE 120MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-10-04

Résumé des caractéristiques du produit

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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
Pr
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
Pr
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
..................................................... 5
4.4
Administration
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