País: Canadá
Idioma: inglés
Fuente: Health Canada
SIMVASTATIN
MYLAN PHARMACEUTICALS ULC
C10AA01
SIMVASTATIN
20MG
TABLET
SIMVASTATIN 20MG
ORAL
30/100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122415003; AHFS:
CANCELLED POST MARKET
2019-09-17
PRODUCT MONOGRAPH PR MYLAN-SIMVASTATIN (Simvastatin Tablets) 5 mg, 10 mg, 20 mg, 40 mg and 80 mg USP Lipid Metabolism Regulator Mylan Pharmaceuticals ULC DATE OF REVISION: July 31, 2019 85 Advance Road Etobicoke, ON Canada M8Z 2S6 Submission Number: 230095 _ _ _Product Monograph –Mylan_-_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 ................................................................................................. 13 DRUG INTERACTIONS ................................................................................................. 16 DOSAGE AND ADMINISTRATION ............................................................................. 20 OVERDOSAGE ............................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 22 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 23 PART II: SCIENTIFIC INFORMATION ............................................................................... 25 PHARMACEUTICAL INFORMATION ......................................................................... 25 CLINICAL TRIALS ......................................................................................................... 27 DETAILED PHARMACOLOGY ................................... Leer el documento completo