PMS-DIMETHYL FUMARATE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DIMETHYL FUMARATE

متاح من:

PHARMASCIENCE 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

_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-DIMETHYL FUMARATE
Dimethyl Fumarate Delayed-Release Capsules
Delayed-Release Capsules, 120 mg and 240 mg, for Oral Use
House Standard
Antineoplastic and Immunomodulating Agents
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Initial Authorization:
OCT 4, 2021
Date of Revision:
NOV 8, 2023
www.pharmascience.com
Submission Control Number: 277364
_pms-DIMETHYL FUMARATE (dimethyl fumarate) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
06/2022
8 ADVERSE REACTIONS, 8.4 Abnormal Laboratory Findings: Hematologic,
Clinical
Chemistry and Other Quantitative Data
05/2023
10 CLINICAL PHARMACOLOGY, 10.2 Pharmacodynamics
05/2023
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
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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5
4.2
Recommended Dose and Dosage Adjustment
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