MINT-ROSUVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

C10AA07

INN (Kansainvälinen yleisnimi):

ROSUVASTATIN

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-06-07

Valmisteyhteenveto

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_ MINT-ROSUVASTATIN (rosuvastatin calcium) _
_Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5 mg, 10 mg, 20 mg, and 40 mg rosuvastatin (as rosuvastatin
calcium), Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
OCT 18, 2021
Date of Revision:
DEC 21, 2023
Submission Control Number: 279257
_ _
_ MINT-ROSUVASTATIN (rosuvastatin calcium) _
_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
4.2 Recommended Dose and Dosage Adjustment
12/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
05/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
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
.................................................