Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
PRAVASTATIN SODIUM
LABORATOIRE RIVA INC.
C10AA03
PRAVASTATIN
10MG
TABLET
PRAVASTATIN SODIUM 10MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563001; AHFS:
CANCELLED POST MARKET
2019-04-02
PRODUCT MONOGRAPH PR RIVA-PRAVASTATIN Pravastatin Sodium Tablets, House Standard 10 mg, 20 mg and 40 mg Lipid Metabolism Regulator LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Québec J7C 3V4 www.labriva.com Date of Revision: June 15, 2017 Submission Control No: 206124 _ _ _RIVA-PRAVASTATIN Product Monograph _ _Page 2 of 41_ 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 .................................................................................................. 14 DOSAGE AND ADMINISTRATION .............................................................................. 16 OVERDOSAGE ................................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 18 STORAGE AND STABILITY ......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ......................................................................... 21 CLINICAL TRIALS .......................................................................................................... 22 DETAILED PHARMACOLOGY .......... Izlasiet visu dokumentu