PRAMIPEXOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-02-2010
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
N04BC05
INN (International Name):
PRAMIPEXOLE
Dosage:
0.25MG
Pharmaceutical form:
TABLET
Composition:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25MG
Administration route:
ORAL
Units in package:
100/1000
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0152169001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-09-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PRAMIPEXOLE
Pramipexole Dihydrochloride Tablets
Tablets 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian Agent / Dopamine Agonist
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Submission Control No. 136335
Date of Preparation:
February 9, 2010
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PRAMIPEXOLE
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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...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
CLINICAL
TRIALS.........................................................................................................
24
DETAILE
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