JAMP RASAGILINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

RASAGILINE (RASAGILINE MESYLATE)

Disponible des:

JAMP PHARMA CORPORATION

Codi ATC:

N04BD02

Designació comuna internacional (DCI):

RASAGILINE

Dosis:

1MG

formulario farmacéutico:

TABLET

Composición:

RASAGILINE (RASAGILINE MESYLATE) 1MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

MONOAMINE OXIDASE B INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2019-09-06

Fitxa tècnica

_Product Monograph of JAMP Rasagiline _
_ Page 1 of 49 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP RASAGILINE
Rasagiline Tablets
Tablet,0.5 mg and 1 mg (as rasagiline mesylate), Oral
Antiparkinson Agent
JAMP Pharma Corporation
Date of Initial Authorization:
1310, rue Nobel September 6, 2019
Boucherville, Quebec Date of Revision:
J4B 5H3, Canada April 11, 2023
Control Number: 267611
_Product Monograph of JAMP Rasagiline _
_ Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
04/2023
7 Warnings and Precautions
04/2023
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
..........................