Country: Canada
Language: English
Source: Health Canada
PRAVASTATIN SODIUM
TEVA CANADA LIMITED
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
APPROVED
2003-01-08
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-PRAVASTATIN pravastatin sodium 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator Teva Canada Limited Date of Revision: 30 Novopharm Court July 14, 2020 Toronto, Ontario Canada M1B 2K9 SUBMISSION CONTROL NO: 240026 _ _ 2 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 ............................................................................................. 15 DOSAGE AND ADMINISTRATION ......................................................................... 17 OVERDOSAGE ........................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 19 STORAGE AND STABILITY ..................................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 21 PART II: SCIENTIFIC INFORMATION ................................................................... 23 PHARMACEUTICAL INFORMATION ..................................................................... 23 CLINICAL TRIALS ..................................................................................................... 24 DETAILED PHARMACOLOGY ................................................................................ 30 TOXICOLOGY ................................................. Read the complete document