PMS-FINGOLIMOD CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

L04AE01

SNN (starptautisko nepatentēto nosaukumu):

FINGOLIMOD

Deva:

0.5MG

Zāļu forma:

CAPSULE

Kompozīcija:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

28

Receptes veids:

Prescription

Ārstniecības joma:

Immunomodulatory Agents

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-03-11

Produkta apraksts

_pms-FINGOLIMOD (fingolimod) _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate Receptor Modulator
PHARMASCIENCE INC.
6111 Ave. Royalmount
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 257639
Date of Initial Authorization
March 11, 2019
Date of revision:
April 6, 2022
_pms-FINGOLIMOD (fingolimod) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
2 Contraindications
04/2022
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...................................................................................................................
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
....................................