PMS-ATORVASTATIN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

C10AA05

INN (International Adı):

ATORVASTATIN

Doz:

40MG

Farmasötik formu:

TABLET

Kompozisyon:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0133055003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-06-08

Ürün özellikleri

_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization
JUN 08, 2018
Date of Revision:
MAR 25, 2022
Submission Control Number: 260400
_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2021
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
03/2022
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..........................