ATORVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-09-2017
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Active ingredient:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
C10AA05
INN (International Name):
ATORVASTATIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133055001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-11-15
Summary of Product characteristics
_ATORVASTATIN Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
Sivem Pharmaceuticals ULC
4705 Dobrin Street
DATE OF REVISION:
September 26, 2017
Saint-Laurent, Quebec
H4R 2P7
Submission Control No.: 209551
_ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
_ _
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
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATIO
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