APO-ATORVASTATIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Disponibil de la:

APOTEX INC

Codul ATC:

C10AA05

INN (nume internaţional):

ATORVASTATIN

Dozare:

20MG

Forma farmaceutică:

TABLET

Compoziție:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG

Calea de administrare:

ORAL

Unități în pachet:

90/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HMG-COA REDUCTASE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2010-05-19

Caracteristicilor produsului

_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