GLN-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DIMETHYL FUMARATE

Beszerezhető a:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC-kód:

L04AX07

INN (nemzetközi neve):

DIMETHYL FUMARATE

Adagolás:

240MG

Gyógyszerészeti forma:

CAPSULE (DELAYED RELEASE)

Összetétel:

DIMETHYL FUMARATE 240MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2021-10-04

Termékjellemzők

_Pr_
_GLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) _
_ _
_ _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-DIMETHYL FUMARATE
dimethyl fumarate delayed-release capsules
delayed-release capsules, 120 mg and 240 mg, oral
Antineoplastic and Immunomodulating Agents
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, ON
L4K 4M2
Date of Initial Authorization:
October 04, 2021
Date of Revision:
November 2, 2023
Submission Control No: 277311
_Pr_
_GLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) _
_ _
_ _
_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2023
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data
11/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
11/2023
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
............................................................................
4
4.1 Dosing Considerations
.........................................................................................