ACH-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DIMETHYL FUMARATE

Dostupno od:

ACCORD HEALTHCARE INC

ATC koda:

L04AX07

INN (International ime):

DIMETHYL FUMARATE

Doziranje:

120MG

Farmaceutski oblik:

CAPSULE (DELAYED RELEASE)

Sastav:

DIMETHYL FUMARATE 120MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

Immunomodulatory Agents

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2021-10-04

Svojstava lijeka

_ACH-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACH-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
delayed-release capsules, 120 mg and 240 mg
Antineoplastic and Immunomodulating Agents
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Submission Control No: 276792
Date of Initial Authorization:
OCT 4, 2021
Date of Revision:
OCT 10, 2023
_ACH-DIMETHYL FUMARATE (dimethyl fumarate delayed-release capsules) _
_Page 2 of 47 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2023
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data
10/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
10/2023
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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