MYLAN-FINGOLIMOD CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

L04AE01

INN (International Name):

FINGOLIMOD

Dosering:

0.5MG

Lægemiddelform:

CAPSULE

Sammensætning:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

28/30/90/500

Recept type:

Prescription

Terapeutisk område:

Immunomodulatory Agents

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2019-03-11

Produktets egenskaber

_MYLAN-FINGOLIMOD (Fingolimod Capsules) _
_Page 1 of 59_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
MAR 11, 2019
Date of Revision:
MAR 23, 2023
Submission Control Number: 269036
_ _
_MYLAN-FINGOLIMOD (Fingolimod Capsules) _
_Page 2 of 59_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2020
4 DOSAGE AND ADMINISTRATION
03/2023
7 WARNINGS AND PRECAUTIONS
03/2023
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
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.4
Administration
........................................................................