NTP-CANDESARTAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CANDESARTAN CILEXETIL

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

C09CA06

INN (Међународно име):

CANDESARTAN

Дозирање:

16MG

Фармацеутски облик:

TABLET

Састав:

CANDESARTAN CILEXETIL 16MG

Пут администрације:

ORAL

Јединице у пакету:

30/100

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0135220003; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2015-08-06

Карактеристике производа

PRODUCT MONOGRAPH
PR
NTP-CANDESARTAN
(Candesartan cilexetil)
8 mg, 16 mg, 32 mg Tablets
Angiotensin II AT
1
Receptor Blocker
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 165862
Date of Preparation:
July 12, 2013
2
TABLE OF CONTENTS
PART I:
HEALTH PROFESSIONAL
INFORMATION................................................. 3
SUMMARY PRODUCT INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
.............................................................. 3
CONTRAINDICATIONS
....................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................. 4
ADVERSE REACTIONS
.....................................................................................
6
DRUG INTERACTIONS
...................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................. 11
OVERDOSAGE
..................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................... 14
STORAGE AND
STABILITY...........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 16
PART II:
SCIENTIFIC INFORMATION
........................................................................
17
CLINICAL TRIALS
...........................................................................................
18
DETAILED PHARMACOLOGY
.....................................................................
20
TOXICOLOGY
..................................................................................................
21
REFERENCES
....................................................................................................
24
PART III
CONSUMER INFORMATION
........................................................................
26
3