Q-PRAVASTATIN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
31-05-2013
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:
QD PHARMACEUTICALS ULC
ATC-kod:
C10AA03
INN (International namn):
PRAVASTATIN
Dos:
10MG
Läkemedelsform:
TABLET
Sammansättning:
PRAVASTATIN SODIUM 10MG
Administreringssätt:
ORAL
Enheter i paketet:
30/100
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0122563001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2015-08-21
Produktens egenskaper
_Page 1 of _
_47_
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
_Page 2 of _
_47_
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
Läs hela dokumentet
