ATORVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Dostopno od:

PRO DOC LIMITEE

Koda artikla:

C10AA05

INN (mednarodno ime):

ATORVASTATIN

Odmerek:

80MG

Farmacevtska oblika:

TABLET

Sestava:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-06-03

Lastnosti izdelka

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