MAR-FINGOLIMOD CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Dostępny od:

MARCAN PHARMACEUTICALS INC

Kod ATC:

L04AA27

INN (International Nazwa):

FINGOLIMOD

Dawkowanie:

0.5MG

Forma farmaceutyczna:

CAPSULE

Skład:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

28

Typ recepty:

Prescription

Dziedzina terapeutyczna:

Immunomodulatory Agents

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-03-11

Charakterystyka produktu

Page 1 of 64
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-FINGOLIMOD
Fingolimod capsules
Capsules, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Manufacturer’s Standard
Sphingosine 1-phosphate receptor modulator
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, ON, K2E 1A2
Date of Initial Authorization:
MAR 11, 2019
Date of Revision:
MAR 03, 2022
Submission Control Number: 257291
Page 2 of 64
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2022
4 Dosage and Administration
03/ 2022
7 Warnings and Precautions
03/ 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
....................................................................