MYLAN-ROSUVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-05-2017
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Active ingredient:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C10AA07
INN (International Name):
ROSUVASTATIN
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5MG
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: 0148963004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-12
Summary of Product characteristics
_Page 1 of 46 _
PRODUCT MONOGRAPH
PR
MYLAN-ROSUVASTATIN
Rosuvastatin Calcium Tablets
5 mg, 10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 205317
Date of Revision: May 11, 2017
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................... 3
SUMMARY PRODUCT INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
.............................................................. 3
CONTRAINDICATIONS
....................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................. 5
ADVERSE REACTIONS
..................................................................................
10
DRUG INTERACTIONS
...................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................. 22
OVERDOSAGE
..................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................... 24
STORAGE AND STABILITY
..........................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 27
PART II: SCIENTIFIC INFORMATION
............................................................... 28
PHARMACEUTICAL INFORMATION
........................................................ 28
CLINICAL TRIALS
..........................................................................................
29
DETAILED PHARMACOLOGY
.....................................................................
33
TOXICOLOGY
..................................................................................................
34
REFERENCES
...................................................................................................
40
P
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