APO-RASAGILINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RASAGILINE (RASAGILINE MESYLATE)

MAH:

APOTEX INC

ATC_code:

N04BD02

INN:

RASAGILINE

dosage:

1MG

pharmaceutical_form:

TABLET

composition:

RASAGILINE (RASAGILINE MESYLATE) 1MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

MONOAMINE OXIDASE B INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2016-01-11

SPC

_APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RASAGILINE
Rasagiline Mesylate Tablets
Tablets, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral
Antiparkinson Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 11, 2016
Date of Revision:
SEP 22, 2023
Submission Control Number: 274257
_APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
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
................................................................. 5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
.............................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.4
Administration
..................................................