APO-ATORVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Dostopno od:

APOTEX INC

Koda artikla:

C10AA05

INN (mednarodno ime):

ATORVASTATIN

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Pot uporabe:

ORAL

Enote v paketu:

90/100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-05-19

Lastnosti izdelka

_APO-ATORVASTATIN (atorvastatin calcium) _
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_Page 1 of 56 _
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