ACT PRAVASTATIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
06-06-2017
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Aktiv bestanddel:
PRAVASTATIN SODIUM
Tilgængelig fra:
ACTAVIS PHARMA COMPANY
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering:
20MG
Lægemiddelform:
TABLET
Sammensætning:
PRAVASTATIN SODIUM 20MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100/500
Recept type:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0122563002; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2018-06-26
Produktets egenskaber
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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
ACT PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
June 2, 2017
Submission Control No: 205793
_ _
_Page 2 of 44_
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
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
.................................................
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