Land: Kanada
Tungumál: enska
Heimild: Health Canada
VALSARTAN
TEVA CANADA LIMITED
C09CA03
VALSARTAN
40MG
TABLET
VALSARTAN 40MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131885003; AHFS:
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH PR NOVO-VALSARTAN (VALSARTAN) 40 MG, 80 MG, 160 MG AND 320 MG TABLETS Angiotensin II AT 1 Receptor Blocker Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 Date of Preparation: October 20, 2010 Control No.: 126534 2 PART I: HEALTH PROFESSIONAL INFORMATION......................................................... 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE................................................................................ 3 CONTRAINDICATIONS ..................................................................................................... 4 WARNINGS AND PRECAUTIONS.................................................................................... 4 DRUG INTERACTIONS .................................................................................................... 10 DOSAGE AND ADMINISTRATION................................................................................ 10 OVERDOSAGE .................................................................................................................. 12 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 12 STORAGE AND STABILITY............................................................................................ 14 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 15 PART II: SCIENTIFIC INFORMATION ............................................................................... 16 PHARMACEUTICAL INFORMATION............................................................................ 17 CLINICAL TRIALS............................................................................................................ 17 DETAILED PHARMACOLOGY....................................................................................... 24 MICROBIOL Lestu allt skjalið