NTP-ATORVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

C10AA05

INN (Међународно име):

ATORVASTATIN

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Пут администрације:

ORAL

Јединице у пакету:

30/100/500

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2016-05-05

Карактеристике производа

_ _
NTP-ATORVASTATIN (Atorvastatin Calcium) Product Monograph_ _
_Page 1 of 50_
PRODUCT MONOGRAPH
Pr
NTP-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium)
LIPID METABOLISM REGULATOR
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
July 5, 2013
Submission Control: 165859
_ _
NTP-ATORVASTATIN (Atorvastatin Calcium) Product Monograph_ _
_Page 2 of 50_
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
…………………………………………..………….……..
17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
………………………………………...……………..
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
...........................................