Q-PRAVASTATIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
31-05-2013
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Aktiv bestanddel:
PRAVASTATIN SODIUM
Tilgængelig fra:
QD PHARMACEUTICALS ULC
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 PRE MARKET
Autorisation dato:
2015-08-21
Produktets egenskaber
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PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32
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