AG-RASAGILINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

RASAGILINE (RASAGILINE MESYLATE)

Disponible desde:

ANGITA PHARMA INC.

Código ATC:

N04BD02

Designación común internacional (DCI):

RASAGILINE

Dosis:

1MG

formulario farmacéutico:

TABLET

Composición:

RASAGILINE (RASAGILINE MESYLATE) 1MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MONOAMINE OXIDASE B INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0151662002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-04-09

Ficha técnica

_Product Monograph of AG-Rasagiline _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-RASAGILINE
Rasagiline Tablets
Tablet, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral
Antiparkinson Agent
Angita Pharma Inc.
1310, rue Nobel
Date of Initial Authorization:
Boucherville, Quebec
APR 09, 2021
J4B 5H3, Canada
Date of Revision:
MAY 25, 2023
Control Number: 275105
_Product Monograph of AG-Rasagiline _
_Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
05/2023
7 Warnings and Precautions
05/2023
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
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................... 5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
6
4.1
Dosing Considerations
..........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
...................................................... 6
4.4
Administration
..............................