AG-RASAGILINE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

RASAGILINE (RASAGILINE MESYLATE)

可用日期:

ANGITA PHARMA INC.

ATC代码:

N04BD02

INN（国际名称）:

RASAGILINE

剂量:

0.5MG

药物剂型:

TABLET

组成:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

MONOAMINE OXIDASE B INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2021-04-09

产品特点

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