PRAVACHOL TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
04-03-2020
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Aktiva substanser:
PRAVASTATIN SODIUM
Tillgänglig från:
BRISTOL-MYERS SQUIBB CANADA
ATC-kod:
C10AA03
INN (International namn):
PRAVASTATIN
Dos:
40MG
Läkemedelsform:
TABLET
Sammansättning:
PRAVASTATIN SODIUM 40MG
Administreringssätt:
ORAL
Enheter i paketet:
90
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0122563003; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2020-11-24
Produktens egenskaper
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRAVACHOL
®
pravastatin sodium
20 and 40 mg
Lipid Metabolism Regulator
Bristol-Myers Squibb Canada
Montréal, Canada
®
Registered trademark
of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Date of Preparation:
August 16, 1990
Date of Revision:
March 4, 2020
Submission Control No: 234107
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_Page 2 of 39_
TABLE OF CONTENTS
PRODUCT MONOGRAPH
.........................................................................................................1
TABLE OF CONTENTS
.................................................................................................................2
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
.....................................................................................................
16
DOSAGE AND ADMINISTRATION
.................................................................................
18
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 19
STORAGE AND STABILITY
.............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 21
PART II
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