APO-ATORVASTATIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Commercializzato da:

APOTEX INC

Codice ATC:

C10AA05

INN (Nome Internazionale):

ATORVASTATIN

Dosaggio:

20MG

Forma farmaceutica:

TABLET

Composizione:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG

Via di somministrazione:

ORAL

Confezione:

90/100/500

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2010-05-19

Scheda tecnica

_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