GALAFOLD CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

MIGALASTAT (MIGALASTAT HYDROCHLORIDE)

Disponível em:

AMICUS THERAPEUTICS CANADA INC.

Código ATC:

A16AX14

DCI (Denominação Comum Internacional):

MIGALASTAT

Dosagem:

123MG

Forma farmacêutica:

CAPSULE

Composição:

MIGALASTAT (MIGALASTAT HYDROCHLORIDE) 123MG

Via de administração:

ORAL

Unidades em pacote:

14

Tipo de prescrição:

Prescription

Área terapêutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0159450001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2017-09-05

Características técnicas

_ _
_GALAFOLD® (migalastat capsules) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GALAFOLD®
Migalastat capsules
Capsules, 123 mg migalastat (as migalastat hydrochloride), Oral
Alpha-galactosidase A (alpha-Gal A) pharmacological chaperone
Amicus Therapeutics Canada Inc.
100 King Street West, Suite 1600
1 First Canadian Place
Toronto ON M5X 1G5
Canada
Imported and Distributed by
:
Innomar Strategies
8030 Esquesing Line
Milton, ON
L9T 6W3
Date of Initial Authorization:
SEP 05, 2017
Date of Revision:
JUL 28, 2023
Submission Control Number: 276328
_ _
_GALAFOLD® (migalastat capsules) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
03/2023
4 Dosage and Administration
03/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
03/2023
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
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
...