PRIVA-PRAVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-09-2015
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Active ingredient:
PRAVASTATIN SODIUM
Available from:
PHARMAPAR INC
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 40MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-07-29
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
PRIVA-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
PHARMAPAR INC.
DATE OF PREPARATION:
100-5950, Ch. de la Côte de Liesse
September 1, 2015
Mont-Royal
Qc, H4T 1E2
Control # 186294
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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
..............................................................................................
5
ADVERSE REACTIONS
..............................................................................................................
10
DRUG INTERACTIONS
..............................................................................................................
13
DOSAGE AND ADMINISTRATION
..........................................................................................
15
OVERDOSAGE
............................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
16
STORAGE AND STABILITY
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 18
PART II: SCIENTIFIC INFORMATION
.....................................................................................
19
PHARMACEUTICAL INFORMATION
......................................................................................
19
C
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