PRZ-ATORVASTATIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ATORVASTATIN (ATORVASTATIN CALCIUM)

זמין מ:

PHARMARIS CANADA INC

קוד ATC:

C10AA05

INN (שם בינלאומי):

ATORVASTATIN

כמות:

10MG

טופס פרצבטיות:

TABLET

הרכב:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

HMG-COA REDUCTASE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0133055001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2021-10-22

מאפייני מוצר

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRZ-ATORVASTATIN
Atorvastatin calcium tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium), Oral
USP
LIPID METABOLISM REGULATOR
Pharmaris Canada Inc.
8310-130 Street, Suite 102
Surrey, British Columbia
Canada, V3W 8J9
Date of Initial Authorization:
OCT 22, 2021
Date of Revision:
FEB 15, 2023
Submission Control No: 268085
_ PRZ-ATORVASTATIN (atorvastatin calcium) _
_ _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
02/2023
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
............................................................................................................
5
2
CONTRAINDICATIONS
........................................................................................................
5
4
DOSAGE AND
ADMINISTRATION........................................................................................
5
4.1
Dosing Considerations
........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 6
4.4
Administration
....................................................................................................
8
4.5
Missed dose
.........................