ASN-RASAGILINE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

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03-05-2019

Virkt innihaldsefni:

RASAGILINE (RASAGILINE MESYLATE)

Fáanlegur frá:

ASCEND LABORATORIES LTD

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

Lækningarsvæði:

MONOAMINE OXIDASE B INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-06-04

Vara einkenni

                                PRODUCT MONOGRAPH
Pr
ASN-RASAGILINE
RASAGILINE MESYLATE
0.5 MG AND 1 MG RASAGILINE TABLETS (AS RASAGILINE MESYLATE)
ANTIPARKINSON AGENT
Ascend Laboratories Ltd.
35 Nixon Road, Unit 10
Caledon, Ontario
L7E 1K1
Date of Preparation:
May 30, 2019
Control Number: 221339
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
.....................................................................................28
T
                                
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