RIVA-PRAVASTATIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
16-06-2017
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Werkstoffen:
PRAVASTATIN SODIUM
Beschikbaar vanaf:
LABORATOIRE RIVA INC.
ATC-code:
C10AA03
INN (Algemene Internationale Benaming):
PRAVASTATIN
Dosering:
10MG
farmaceutische vorm:
TABLET
Samenstelling:
PRAVASTATIN SODIUM 10MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
HMG-COA REDUCTASE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0122563001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2019-04-02
Productkenmerken
PRODUCT MONOGRAPH
PR
RIVA-PRAVASTATIN
Pravastatin Sodium Tablets, House Standard
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Date of Revision:
June 15, 2017
Submission Control No: 206124
_ _
_RIVA-PRAVASTATIN Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
..........................................................................................................
22
DETAILED PHARMACOLOGY
..........
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