NTP-PRAVASTATIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
30-07-2013
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Aktiv bestanddel:
PRAVASTATIN SODIUM
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
PRAVASTATIN SODIUM 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0122563001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2017-06-13
Produktets egenskaber
PRODUCT MONOGRAPH
Pr
NTP-PRAVASTATIN
pravastatin sodium tablets
10, 20 and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166140
Date of Preparation:
July 23, 2013
_ _
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
PART II: SCIENTIFIC INFORMATION
................................................................... 21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
.....................................................................................................
22
DETAILED PHARMACOLOGY
................................................................................
28
TOXICOLOGY
............................................................................................................
29
REFERENCES
................................................
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