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:

20MG

Farmasötik formu:

TABLET

Kompozisyon:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

Uygulama yolu:

ORAL

Paketteki üniteler:

90/500

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2019-07-31

Ürün özellikleri

PRODUCT MONOGRAPH
PR
PMS-ATORVASTATIN
(Atorvastatin Calcium Tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 30, 2016
Submission Control No: 195540
_ _
_pms-ATORVASTATIN Product Monograph _
_Page 2 of 52 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
...........................