PMS-ATORVASTATIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
04-07-2016
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Aktiv ingrediens:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
C10AA05
INN (International Name):
ATORVASTATIN
Dosering :
40MG
Legemiddelform:
TABLET
Sammensetning:
ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
Administreringsrute:
ORAL
Enheter i pakken:
90/500
Resept typen:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0133055003; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2019-07-31
Preparatomtale
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
...........................
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