AG-RASAGILINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

RASAGILINE (RASAGILINE MESYLATE)

Disponible des:

ANGITA PHARMA INC.

Codi ATC:

N04BD02

Designació comuna internacional (DCI):

RASAGILINE

Dosis:

0.5MG

formulario farmacéutico:

TABLET

Composición:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

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: 0151662001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-04-09

Fitxa tècnica

_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
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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
..............................