PRAVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PRAVASTATIN SODIUM

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

C10AA03

INN (International Name):

PRAVASTATIN

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

PRAVASTATIN SODIUM 20MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122563002; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-09-21

Summary of Product characteristics

_PRAVASTATIN Product Monograph_
Page 1 of 40
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
pravastatin sodium tablets USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
SIVEM PHARMACEUTICALS ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
CONTROL NUMBER: 280722
DATE OF
PREPARATION:
JUL
23, 2012
DATE
OF
REVISION
NOV 27, 2023
_PRAVASTATIN Product Monograph_
Page 2 of 40
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
..................................................................................................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
..............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................23
CLINICAL TRIALS
........................................................................................................