ATORVASTATIN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Mevcut itibaren:

SIVEM PHARMACEUTICALS ULC

ATC kodu:

C10AA05

INN (International Adı):

ATORVASTATIN

Doz:

40MG

Farmasötik formu:

TABLET

Kompozisyon:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2018-05-09

Ürün özellikleri

_ATORVASTATIN Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
Sivem Pharmaceuticals ULC
4705 Dobrin Street
DATE OF REVISION:
September 26, 2017
Saint-Laurent, Quebec
H4R 2P7
Submission Control No.: 209551
_ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
_ _
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
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATIO