ATORVASTATIN-10 TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Mevcut itibaren:

SIVEM PHARMACEUTICALS ULC

ATC kodu:

C10AA05

INN (International Adı):

ATORVASTATIN

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

90/100/500

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-08-29

Ürün özellikleri

_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN-10
PR
ATORVASTATIN-20
PR
ATORVASTATIN-40
PR
ATORVASTATIN-80
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
Sivem Pharmaceuticals ULC
Date of Initial Authorization:
4705 Dobrin Street
August 29, 2013
Saint-Laurent, Quebec, Canada
H4R 2P7
Date of Revision:
www.sivem.ca
March 14, 2023
Submission Control Number: 268525
_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
_ _
_ _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2023
7 Warnings and Precautions, Musculoskeletal
03/2023
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
..........................