MINT-RASAGILINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

RASAGILINE (RASAGILINE MESYLATE)

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

N04BD02

INN (שם בינלאומי):

RASAGILINE

כמות:

1MG

טופס פרצבטיות:

TABLET

הרכב:

RASAGILINE (RASAGILINE MESYLATE) 1MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2022-12-21

מאפייני מוצר

_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
........