MINT-RASAGILINE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RASAGILINE (RASAGILINE MESYLATE)

Fáanlegur frá:

MINT PHARMACEUTICALS INC

ATC númer:

N04BD02

INN (Alþjóðlegt nafn):

RASAGILINE

Skammtar:

0.5MG

Lyfjaform:

TABLET

Samsetning:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-12-21

Vara einkenni

_MINT-RASAGILINE _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-RASAGILINE
Rasagiline Tablets
Tablet, 0.5 mg and 1 mg (as rasagiline mesylate), Oral
Professed Standard
Antiparkinson Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
December 20, 2022
Submission Control Number: 250188
_ _
_MINT-RASAGILINE _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
6
4.5
Missed Dose
........