Q-GEN ATORVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Доступно од:

Q-GEN PHARMACEUTICALS INC

АТЦ код:

C10AA05

INN (Међународно име):

ATORVASTATIN

Дозирање:

80MG

Фармацеутски облик:

TABLET

Састав:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0133055004; AHFS:

Статус ауторизације:

CANCELLED (UNRETURNED ANNUAL)

Датум одобрења:

2017-09-05

Карактеристике производа

PRODUCT MONOGRAPH
Q-GEN ATORVASTATIN®
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Q-Gen Pharmaceuticals Inc.
DATE OF PREPARATION:
1100 Central Park West
November 30, 2011
Mississauga, ON, L5C 4E5
CONTROL # 150711
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
............................................................21
STORAGE AND
STABILITY..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIALS..........................................................................................................28
DETAILED
PHA