PRAVASTATIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
10-09-2013
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Aktiv ingrediens:
PRAVASTATIN SODIUM
Tilgjengelig fra:
MELIAPHARM INC
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering :
20MG
Legemiddelform:
TABLET
Sammensetning:
PRAVASTATIN SODIUM 20MG
Administreringsrute:
ORAL
Enheter i pakken:
100/500
Resept typen:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0122563002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2014-06-25
Preparatomtale
PRODUCT MONOGRAPH
PR
PRAVASTATIN
Pravastatin Sodium Tablets, House Standard
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
September 10, 2013
Submission Control No: 167055
_ _
_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
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
..........................................................................................................
22
DETAILED PHARMACOLOGY
...........................
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