TEVA-FINGOLIMOD CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

L04AE01

INN (שם בינלאומי):

FINGOLIMOD

כמות:

0.5MG

טופס פרצבטיות:

CAPSULE

הרכב:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/90

סוג מרשם:

Prescription

איזור תרפויטי:

Immunomodulatory Agents

leaflet_short:

Active ingredient group (AIG) number: 0152886001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2019-03-11

מאפייני מוצר

_Teva-Fingolimod Page 1 of 66 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg Fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
March 11, 2019
Date of Revision:
April 20, 2022
Submission Control Number: 259158
_Teva-Fingolimod Page 2 of 66 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
02/2020
4 Dosage and Administration
04/2022
7 Warnings and Precautions
04/2022
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........................................................................
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............................................................................................................
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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7
4.4 Administration
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