PRAVACHOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PRAVASTATIN SODIUM

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

C10AA03

INN (International Name):

PRAVASTATIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

PRAVASTATIN SODIUM 10MG

Administration route:

ORAL

Units in package:

90

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122563001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-06-14

Summary of Product characteristics

_ _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PRAVACHOL
®
pravastatin sodium
10, 20, 40 and 80 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 20, 2017
SUBMISSION CONTROL NO: 200020
_ _
_Page 2 of 46_
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
.....................................................................................
6
ADVERSE REACTIONS
.....................................................................................................
12
DRUG INTERACTIONS
.....................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................
19
OVERDOSAGE
...................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
.............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................