ATORVASTATIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Disponibbli minn:

SANIS HEALTH INC

Kodiċi ATC:

C10AA05

INN (Isem Internazzjonali):

ATORVASTATIN

Dożaġġ:

20MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HMG-COA REDUCTASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0133055002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2012-12-18

Karatteristiċi tal-prodott

_ATORVASTATIN (atorvastatin calcium) _
_ _
_ _
_ _
_ _
_ _
_ Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin
(as atorvastatin calcium propylene glycol solvate), Oral
USP
Lipid Metabolism Regulator
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
July 30, 2020
Date of Revision:
August 22, 2022
Submission Control Number: 265202
_ATORVASTATIN (atorvastatin calcium) _
_ _
_ _
_ _
_ _
_ _
_ Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
08/2022
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
...........................................