PMS-ATORVASTATIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
04-07-2016
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Werkstoffen:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
C10AA05
INN (Algemene Internationale Benaming):
ATORVASTATIN
Dosering:
80MG
farmaceutische vorm:
TABLET
Samenstelling:
ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG
Toedieningsweg:
ORAL
Eenheden in pakket:
90/500
Prescription-type:
Prescription
Therapeutisch gebied:
HMG-COA REDUCTASE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0133055004; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2019-07-31
Productkenmerken
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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