GLN-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DIMETHYL FUMARATE

متاح من:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC رمز:

L04AX07

INN (الاسم الدولي):

DIMETHYL FUMARATE

جرعة:

120MG

الشكل الصيدلاني:

CAPSULE (DELAYED RELEASE)

تركيب:

DIMETHYL FUMARATE 120MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-10-04

خصائص المنتج

_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
.........................................................................................