SANDOZ CINACALCET TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CINACALCET (CINACALCET HYDROCHLORIDE)

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

H05BX01

ІПН (Міжнародна Ім'я):

CINACALCET

Дозування:

90MG

Фармацевтична форма:

TABLET

Склад:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30

Тип рецепту:

Prescription

Терапевтична области:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2021-04-21

Характеристики продукта

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_Sandoz Cinacalcet _
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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
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_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
...........................................