ATORVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступно од:

ACTAVIS PHARMA COMPANY

АТЦ код:

C10AA05

INN (Међународно име):

ATORVASTATIN

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Пут администрације:

ORAL

Јединице у пакету:

30/90/500

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2017-09-01

Карактеристике производа

PRODUCT MONOGRAPH
PR
ATORVASTATIN
Atorvastatin calcium tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Control No.: 179022
Date of Preparation:
November 6, 2014
_ _
_Product Monograph –ATORVASTATIN _
_Page 2 of 53_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
21
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
......................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.........................................................................
27
CLINICAL TRIALS
.................................................