ATORVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Saatavilla:

PRO DOC LIMITEE

ATC-koodi:

C10AA05

INN (Kansainvälinen yleisnimi):

ATORVASTATIN

Annos:

80MG

Lääkemuoto:

TABLET

Koostumus:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Antoreitti:

ORAL

Kpl paketissa:

30/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0133055004; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2010-06-03

Valmisteyhteenveto

_ATORVASTATIN (atorvastatin calcium) _
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_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
PRO DOC LTÉE.
2925, Boul. Industriel
Laval, Québec
Canada H7L 3W9
Date of Initial Authorization:
July 27, 2010
Date of Revision:
June 27, 2022
Submission Control Number: 264735
_ATORVASTATIN (atorvastatin calcium) _
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_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2022
7 Warnings and Precautions, Musculoskeletal
06/2022
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
...................................................