AG-ROSUVASTATIN CALCIUM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-07-2023
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Active ingredient:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
Available from:
ANGITA PHARMA INC.
ATC code:
C10AA07
INN (International Name):
ROSUVASTATIN
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0148963004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-06-15
Summary of Product characteristics
AG-Rosuvastatin Calcium
(rosuvastatin calcium)
PRODUCT MONOGRAPH Page 1 of 50
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-ROSUVASTATIN CALCIUM
Rosuvastatin Calcium Tablets
Tablets, 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin (as rosuvastatin
calcium), Oral
House Standard
Lipid Metabolism Regulator
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
JUN 15, 2020
Date of Revision:
JUL 11, 2023
Submission Control Number: 276283
AG-Rosuvastatin Calcium
(rosuvastatin calcium)
PRODUCT MONOGRAPH Page 2 of 50
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS
..................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................... 5
4.4
Administration
............................................................................................................
7
4.5
Missed Dose
.....................................................
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