ACH-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DIMETHYL FUMARATE

Tilgængelig fra:

ACCORD HEALTHCARE INC

ATC-kode:

L04AX07

INN (International Name):

DIMETHYL FUMARATE

Dosering:

240MG

Lægemiddelform:

CAPSULE (DELAYED RELEASE)

Sammensætning:

DIMETHYL FUMARATE 240MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-10-04

Produktets egenskaber

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