Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
MYLAN PHARMACEUTICALS ULC
C10AA07
ROSUVASTATIN
10MG
TABLET
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG
ORAL
30/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0148963001; AHFS:
CANCELLED POST MARKET
2018-04-10
_Page 1 of 46 _ PRODUCT MONOGRAPH PR MYLAN-ROSUVASTATIN Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg LIPID METABOLISM REGULATOR Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control No.: 205317 Date of Revision: May 11, 2017 _Page 2 of 46_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................... 3 SUMMARY PRODUCT INFORMATION ........................................................ 3 INDICATIONS AND CLINICAL USE .............................................................. 3 CONTRAINDICATIONS .................................................................................... 4 WARNINGS AND PRECAUTIONS .................................................................. 5 ADVERSE REACTIONS .................................................................................. 10 DRUG INTERACTIONS ................................................................................... 16 DOSAGE AND ADMINISTRATION .............................................................. 22 OVERDOSAGE .................................................................................................. 24 ACTION AND CLINICAL PHARMACOLOGY ........................................... 24 STORAGE AND STABILITY .......................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 27 PART II: SCIENTIFIC INFORMATION ............................................................... 28 PHARMACEUTICAL INFORMATION ........................................................ 28 CLINICAL TRIALS .......................................................................................... 29 DETAILED PHARMACOLOGY ..................................................................... 33 TOXICOLOGY .................................................................................................. 34 REFERENCES ................................................................................................... 40 P Izlasiet visu dokumentu