ACT PRAVASTATIN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
06-06-2017
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
PRAVASTATIN SODIUM
Tillgänglig från:
ACTAVIS PHARMA COMPANY
ATC-kod:
C10AA03
INN (International namn):
PRAVASTATIN
Dos:
40MG
Läkemedelsform:
TABLET
Sammansättning:
PRAVASTATIN SODIUM 40MG
Administreringssätt:
ORAL
Enheter i paketet:
30/100/500
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0122563003; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2018-06-26
Produktens egenskaper
_ _
_ _
_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
.................................................
Läs hela dokumentet
