MYLAN-ATORVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-05-2016
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Active ingredient:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C10AA05
INN (International Name):
ATORVASTATIN
Dosage:
80MG
Pharmaceutical form:
TABLET
Composition:
ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG
Administration route:
ORAL
Units in package:
90
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133055004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-05-20
Summary of Product characteristics
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_Page 1_
I
PRODUCT MONOGRAPH
PR
MYLAN-ATORVASTATIN
ATORVASTATIN CALCIUM TABLETS
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
DATE OF REVISION : MAY 3, 2016
SUBMISSION CONTROL NO.: 194039
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_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
............................................................................................................
11
DRUG INTERACTIONS
............................................................................................................
14
DOSAGE AND ADMINISTRATION
........................................................................................
22
OVERDOSAGE
..........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
24
STORAGE AND STABILITY
....................................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................
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