ACH-FINGOLIMOD CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Tillgänglig från:

ACCORD HEALTHCARE INC

ATC-kod:

L04AE01

INN (International namn):

FINGOLIMOD

Dos:

0.5MG

Läkemedelsform:

CAPSULE

Sammansättning:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Administreringssätt:

ORAL

Enheter i paketet:

7/90/1000

Receptbelagda typ:

Prescription

Terapiområde:

Immunomodulatory Agents

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2019-03-29

Produktens egenskaper

_ACH-Fingolimod (Fingolimod Capsules) _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Accord Healthcare Inc.
3535 Boul. St-Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
March 29, 2019
Date of Revision:
February 23, 2022
Submission Control Number: 259829
_ACH-Fingolimod (Fingolimod Capsules) _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
02/2022
7 Warnings and Precautions
02/2022
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
............................................................................................................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.....................................................................................................8
4.5
Missed