Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
LOVASTATIN
SANDOZ CANADA INCORPORATED
C10AA02
LOVASTATIN
40MG
TABLET
LOVASTATIN 40MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0120669001; AHFS:
CANCELLED POST MARKET
2019-08-01
_ _ _Sandoz Lovastatin _ _Page 1 of 43_ PRODUCT MONOGRAPH PR SANDOZ LOVASTATIN Lovastatin Tablets USP 20 mg and 40 mg Lipid Metabolism Regulator Sandoz Canada Inc. 145 Jules-Léger Boucherville, QC J4B 7K8 Date of Revision: March 20, 2014 Submission Control Number: 172518 _ _ _Sandoz Lovastatin _ _Page 2 of 43_ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................20 PART II: SCIENTIFIC INFORMATION ...............................................................................21 PHARMACEUTICAL INFORMATION ..........................................................................21 CLINICAL TRIALS ..........................................................................................................22 DETAILED PHARMACOLOGY ............................................ Կարդացեք ամբողջական փաստաթուղթը