NOVO-ATORVASTATIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
13-05-2011
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Werkstoffen:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Beschikbaar vanaf:
NOVOPHARM LIMITED
ATC-code:
C10AA05
INN (Algemene Internationale Benaming):
ATORVASTATIN
Dosering:
20MG
farmaceutische vorm:
TABLET
Samenstelling:
ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
HMG-COA REDUCTASE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0133055002; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2015-10-26
Productkenmerken
_Page 1_
PRODUCT MONOGRAPH
Pr
NOVO-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as
atorvastatin calcium
)
LIPID METABOLISM REGULATOR
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 145821
Date of revision:
May 6, 2011
_Page 2_
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.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.........................................................................................................
26
DETAILED
PHARMACOLOGY............................................................
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