TEVA-FINGOLIMOD CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

L04AE01

INN（国際名）:

FINGOLIMOD

投薬量:

0.5MG

医薬品形態:

CAPSULE

構図:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

投与経路:

ORAL

パッケージ内のユニット:

30/90

処方タイプ:

Prescription

治療領域:

Immunomodulatory Agents

製品概要:

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

認証ステータス:

APPROVED

承認日:

2019-03-11

製品の特徴

_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
................................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1 INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
.........................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
......................................................................
7
4.4 Administration
....................................................