ATORVASTATIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Verfügbar ab:

PRO DOC LIMITEE

ATC-Code:

C10AA05

INN (Internationale Bezeichnung):

ATORVASTATIN

Dosierung:

80MG

Darreichungsform:

TABLET

Zusammensetzung:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100

Verschreibungstyp:

Prescription

Therapiebereich:

HMG-COA REDUCTASE INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-06-03

Fachinformation

_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
...................................................