Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM)
PHARMASCIENCE INC
C10AA05
ATORVASTATIN
10MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG
ORAL
90/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055001; AHFS:
CANCELLED POST MARKET
2019-07-31
PRODUCT MONOGRAPH PR PMS-ATORVASTATIN (Atorvastatin Calcium Tablets) 10 mg, 20 mg, 40 mg and 80 mg atorvastatin LIPID METABOLISM REGULATOR PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 www.pharmascience.com Date of Revision: June 30, 2016 Submission Control No: 195540 _ _ _pms-ATORVASTATIN Product Monograph _ _Page 2 of 52 _ 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 ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................22 STORAGE AND STABILITY ..........................................................................................25 SPECIAL HANDLING INSTRUCTIONS .......................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ...............................................................................27 PHARMACEUTICAL INFORMATION ..........................................................................27 CLINICAL TRIALS ........................... Izlasiet visu dokumentu