APO-RASAGILINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RASAGILINE (RASAGILINE MESYLATE)

Disponibil de la:

APOTEX INC

Codul ATC:

N04BD02

INN (nume internaţional):

RASAGILINE

Dozare:

0.5MG

Forma farmaceutică:

TABLET

Compoziție:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MONOAMINE OXIDASE B INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-01-11

Caracteristicilor produsului

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