JAMP RASAGILINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-09-2019
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Active ingredient:
RASAGILINE (RASAGILINE MESYLATE)
Available from:
JAMP PHARMA CORPORATION
ATC code:
N04BD02
INN (International Name):
RASAGILINE
Dosage:
0.5MG
Pharmaceutical form:
TABLET
Composition:
RASAGILINE (RASAGILINE MESYLATE) 0.5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MONOAMINE OXIDASE B INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0151662001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-09-06
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
JAMP RASAGILINE
(RASAGILINE TABLETS)
0.5 MG AND 1 MG RASAGILINE
(AS RASAGILINE MESYLATE)
ANTIPARKINSON AGENT
JAMP Pharma Corporation
Date of Preparation: September 4, 2019
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Control Number: 224660
_Product Monograph of Jamp Rasagiline_
_Page 2 of 43_
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
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
.................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
.............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................23
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMACOLOGY
....................................
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