JAMP-PRAVASTATIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
28-07-2020
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Werkstoffen:
PRAVASTATIN SODIUM
Beschikbaar vanaf:
JAMP PHARMA CORPORATION
ATC-code:
C10AA03
INN (Algemene Internationale Benaming):
PRAVASTATIN
Dosering:
40MG
farmaceutische vorm:
TABLET
Samenstelling:
PRAVASTATIN SODIUM 40MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100/500
Prescription-type:
Prescription
Therapeutisch gebied:
HMG-COA REDUCTASE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0122563003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2015-06-19
Productkenmerken
Page 1 of 39
PRODUCT MONOGRAPH
Pr
JAMP-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
July 8, 2020
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No.: 240031
Page 2 of 39
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
........................................................................................................................
11
DRUG INTERACTIONS
........................................................................................................................
15
DOSAGE AND ADMINISTRATION
....................................................................................................
17
OVERDOSAGE
.......................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
19
STORAGE AND STABILITY
................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
21
PART II: SCIENTIFIC INFORMATION
...................................................................................................
22
PHARMACEUTICAL INFORMAT
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