TARO-PRAVASTATIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
08-12-2022
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Aktiv ingrediens:
PRAVASTATIN SODIUM
Tilgjengelig fra:
SUN PHARMA CANADA INC
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering :
40MG
Legemiddelform:
TABLET
Sammensetning:
PRAVASTATIN SODIUM 40MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100
Resept typen:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0122563003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2022-12-09
Preparatomtale
_Pr_
_TARO-PRAVASTATIN Product Monograph_ Page 1 of 39
PRODUCT MONOGRAPH
Pr
TARO-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Sun Pharma Canada Inc.
126
East Drive
Brampton, Ontario
L6T 1C1
Control#
269572
Date of Preparation:
AUG 14, 2020
Date of Revision:
DEC
08, 2022
_Pr_
_TARO-PRAVASTATIN Product Monograph_ 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
...................................................................................
18
STORAGE AND STABILITY
................................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
20
PART II: SCIENTIFIC INFORMATION
...................................
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