M-ROSUVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Available from:

MANTRA PHARMA INC

ATC code:

C10AA07

INN (International Name):

ROSUVASTATIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0148963001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-10-19

Summary of Product characteristics

_M-ROSUVASTATIN_
_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
M-ROSUVASTATIN
Rosuvastatin Tablets
Tablets, 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin (as rosuvastatin
calcium), Oral Use
USP
Lipid Metabolism Regulator
Mantra Pharma Inc.
1000 Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3
Submission Control Number: 279319
Date of
Initial Authorization:
FEB 25, 2020
Date of Revision:
OCT
18, 2023
_M-ROSUVASTATIN_
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
4.2 Recommended Dose and Dosage Adjustment
10/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
10/2023
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
......................................................................
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
.......................................................................................................