Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
EZETIMIBE
MYLAN PHARMACEUTICALS ULC
C10AX09
EZETIMIBE
10MG
TABLET
EZETIMIBE 10MG
ORAL
30/100/500
Prescription
CHOLESTEROL ABSORPTION INHIBITORS
Active ingredient group (AIG) number: 0149164001; AHFS:
CANCELLED POST MARKET
2017-05-08
Page 1 of 30 PRODUCT MONOGRAPH PR MYLAN-EZETIMIBE Ezetimibe Tablets 10 mg Cholesterol Absorption Inhibitor Professed Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke ON M9Z 2S6 Date of Revision: January 08, 2015 Submission Control No: 180299 Page 2 of 30 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION............................................... 3 SUMMARY PRODUCT INFORMATION ..................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................... 4 ADVERSE REACTIONS ................................................................................................. 7 DRUG INTERACTIONS ............................................................................................... 11 DOSAGE AND ADMINISTRATION ........................................................................... 12 OVEROSAGE ................................................................................................................. 13 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 14 STORAGE AND STABILITY ....................................................................................... 15 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 15 PART II: SCIENTIFIC INFORMATION ..................................................................... 17 PHARMACEUTICAL INFORMATION ....................................................................... 17 CLINICAL TRIALS ....................................................................................................... 18 TOXICOLOGY ............................................................................................................... 22 REFERENCES ........................ Belgenin tamamını okuyun