APO-RASAGILINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RASAGILINE (RASAGILINE MESYLATE)

Available from:

APOTEX INC

ATC code:

N04BD02

INN (International Name):

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

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2016-01-11

Summary of Product characteristics

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