PMS-ATORVASTATIN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
04-07-2016
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Aktiva substanser:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Tillgänglig från:
PHARMASCIENCE INC
ATC-kod:
C10AA05
INN (International namn):
ATORVASTATIN
Dos:
40MG
Läkemedelsform:
TABLET
Sammansättning:
ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG
Administreringssätt:
ORAL
Enheter i paketet:
90/500
Receptbelagda typ:
Prescription
Terapiområde:
HMG-COA REDUCTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0133055003; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2019-07-31
Produktens egenskaper
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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