APO-ATORVASTATIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Verfügbar ab:

APOTEX INC

ATC-Code:

C10AA05

INN (Internationale Bezeichnung):

ATORVASTATIN

Dosierung:

10MG

Darreichungsform:

TABLET

Zusammensetzung:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

90/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

HMG-COA REDUCTASE INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-05-19

Fachinformation

_APO-ATORVASTATIN (atorvastatin calcium) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-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
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
MAY 19, 2010
Date of Revision:
APR 19,
2022
Submission Control Number: 260660
_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 2 of 56 _
_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 3 of 56 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
04/2022
7 Warnings and Precautions, Musculoskeletal
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
3
TABLE OF CONTENTS
.........................................................................................................
3
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
5
1
INDICATIONS
.................................................................................................................
5
1.1
Pediatrics
...............................................................................................................
5
1.2
Geriatrics
................................................................................................................
6
2
CONTRAINDICATIONS
..................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment......................................................... 7