TEVA-RASAGILINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RASAGILINE (RASAGILINE MESYLATE)

Available from:

TEVA CANADA LIMITED

ATC code:

N04BD02

INN (International Name):

RASAGILINE

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

RASAGILINE (RASAGILINE MESYLATE) 1MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MONOAMINE OXIDASE B INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2013-12-13

Summary of Product characteristics

TEVA-RASAGILINE
Page 1 of 48
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-RASAGILINE
Rasagiline Mesylate Tablets
Tablets, 0.5 mg and 1 mg , Oral
ANTIPARKINSON AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario,
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
August 18, 2014
Date of Revision:
September 22, 2022
Submission Control Number: 263230
RECENT MAJOR LABEL CHANGES
TEVA-RASAGILINE
Page 2 of 48
2 Contraindications
09/2022
7 Warnings and Precautions
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
1
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
...................................................................................................
7
4