SANDOZ CINACALCET TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

CINACALCET (CINACALCET HYDROCHLORIDE)

Доступна с:

SANDOZ CANADA INCORPORATED

код АТС:

H05BX01

ИНН (Международная Имя):

CINACALCET

дозировка:

90MG

Фармацевтическая форма:

TABLET

состав:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Администрация маршрут:

ORAL

Штук в упаковке:

30

Тип рецепта:

Prescription

Терапевтические области:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0150282003; AHFS:

Статус Авторизация:

CANCELLED PRE MARKET

Дата Авторизация:

2021-04-21

Характеристики продукта

_ _
_Sandoz Cinacalcet _
_Page 1 of 26 _
PRODUCT MONOGRAPH
PR
SANDOZ CINACALCET
Cinacalcet Tablets
30 mg, 60 mg and 90 mg cinacalcet (as cinacalcet hydrochloride)
Calcimimetic agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of revision:
December 9, 2019
Submission Control No: 234104
_ _
_Sandoz Cinacalcet _
_Page 2 of 26 _
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
...............................................................................................
8
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
..........................................................................
12
OVERDOSAGE
...........................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 14
STORAGE AND STABILITY
.....................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
......................................................................
16
CLINICAL TRIALS
.....................................................................................................
17
DETAILED PHARMACOLOGY
...........................................