AG-RASAGILINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

RASAGILINE (RASAGILINE MESYLATE)

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

N04BD02

INN (שם בינלאומי):

RASAGILINE

כמות:

0.5MG

טופס פרצבטיות:

TABLET

הרכב:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

MONOAMINE OXIDASE B INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0151662001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2021-04-09

מאפייני מוצר

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