Q-PRAVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-05-2013
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Active ingredient:
PRAVASTATIN SODIUM
Available from:
QD PHARMACEUTICALS ULC
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 10MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2015-08-21
Summary of Product characteristics
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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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