देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM)
MYLAN PHARMACEUTICALS ULC
C10AA05
ATORVASTATIN
40MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
ORAL
90/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055003; AHFS:
CANCELLED POST MARKET
2016-05-20
_ _ _ _ _Page 1_ I PRODUCT MONOGRAPH PR MYLAN-ATORVASTATIN ATORVASTATIN CALCIUM TABLETS 10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN LIPID METABOLISM REGULATOR Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 DATE OF REVISION : MAY 3, 2016 SUBMISSION CONTROL NO.: 194039 _ _ _Page 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 ............................................................................................................ 14 DOSAGE AND ADMINISTRATION ........................................................................................ 22 OVERDOSAGE .......................................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ...................................................................... 24 STORAGE AND STABILITY .................................................................................................... 27 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ....................................................... 27 PART II: SCIENTIFIC INFORMATION .................................................................................. 28 PHARMACEUTICAL INFORMATION ....................................... पूरा दस्तावेज़ पढ़ें