Land: Kanada
Språk: engelska
Källa: Health Canada
SIMVASTATIN
SANDOZ CANADA INCORPORATED
C10AA01
SIMVASTATIN
80MG
TABLET
SIMVASTATIN 80MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122415005; AHFS:
CANCELLED POST MARKET
2021-04-13
_ _ _Sandoz Simvastatin _ _Page 1 of 50_ _ _ PRODUCT MONOGRAPH PR SANDOZ SIMVASTATIN SIMVASTATIN TABLETS, USP 5 MG, 10 MG, 20 MG, 40 MG AND 80 MG LIPID METABOLISM REGULATOR Sandoz Canada Inc. Date of Revision: 145 Jules-Léger January 4, 2018 Boucherville, Quebec J4B 7K8 Submission Control No.: 211930 _ _ _Sandoz Simvastatin _ _Page 2 of 50_ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23 PART II: SCIENTIFIC INFORMATION ...............................................................................24 PHARMACEUTICAL INFORMATION ..........................................................................24 CLINICAL TRIALS ..........................................................................................................25 DETAILED PHARMACOLOGY ............. Läs hela dokumentet