SANDOZ FINGOLIMOD CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Pieejams no:

SANDOZ CANADA INCORPORATED

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

_Sandoz Fingolimod _
_Page 1 of 68 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ
® FINGOLIMOD
Fingolimod capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Sandoz Canada Inc.
110, Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Inital Authorization:
October 31, 2019
Date of Revision:
February 23, 2022
Submission Control No: 256559
_Sandoz Fingolimod _
_Page 2 of 68 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
02/2022
4 Dosage and administration
02/2022
7 Warnings and Precautions
02/2022
TABLE OF CONTENTS
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
DOSE.......................................................................................................