AG-RASAGILINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RASAGILINE (RASAGILINE MESYLATE)

Διαθέσιμο από:

ANGITA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

N04BD02

INN (Διεθνής Όνομα):

RASAGILINE

Δοσολογία:

1MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RASAGILINE (RASAGILINE MESYLATE) 1MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MONOAMINE OXIDASE B INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-04-09

Αρχείο Π.Χ.Π.

_Product Monograph of AG-Rasagiline _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-RASAGILINE
Rasagiline Tablets
Tablet, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral
Antiparkinson Agent
Angita Pharma Inc.
1310, rue Nobel
Date of Initial Authorization:
Boucherville, Quebec
APR 09, 2021
J4B 5H3, Canada
Date of Revision:
MAY 25, 2023
Control Number: 275105
_Product Monograph of AG-Rasagiline _
_Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
05/2023
7 Warnings and Precautions
05/2023
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
.......................................................................
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
..............................