NU-PRAVASTATIN TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-03-2011
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
PRAVASTATIN SODIUM
Available from:
NU-PHARM INC
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 20MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-09-04
Summary of Product characteristics
Page 1 of 42
PRODUCT MONOGRAPH
Pr
NU-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
NU-PHARM INC.
1165 CREDITSTONE ROAD, UNIT 2
VAUGHAN, ON
DATE OF REVISION:
L4K 4N7
MARCH 3, 2011
_CONTROL # 144758 _
Page 2 of 42
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.......................................................................................................
10
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
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.....................................
Read the complete document
