MAR-FINGOLIMOD CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Disponível em:

MARCAN PHARMACEUTICALS INC

Código ATC:

L04AA27

DCI (Denominação Comum Internacional):

FINGOLIMOD

Dosagem:

0.5MG

Forma farmacêutica:

CAPSULE

Composição:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Via de administração:

ORAL

Unidades em pacote:

28

Tipo de prescrição:

Prescription

Área terapêutica:

Immunomodulatory Agents

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2019-03-11

Características técnicas

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
....................................................................