JAMP DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DIMETHYL FUMARATE

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

L04AX07

DCI (Denominação Comum Internacional):

DIMETHYL FUMARATE

Dosagem:

120MG

Forma farmacêutica:

CAPSULE (DELAYED RELEASE)

Composição:

DIMETHYL FUMARATE 120MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2021-10-04

Características técnicas

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