SANDOZ SIMVASTATIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SIMVASTATIN

Предлага се от:

SANDOZ CANADA INCORPORATED

АТС код:

C10AA01

INN (Международно Name):

SIMVASTATIN

дозиране:

80MG

Лекарствена форма:

TABLET

Композиция:

SIMVASTATIN 80MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

HMG-COA REDUCTASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0122415005; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2021-04-13

Данни за продукта

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_Sandoz Simvastatin _
_Page 1 of 50_
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PRODUCT MONOGRAPH
PR
SANDOZ SIMVASTATIN
SIMVASTATIN TABLETS, USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
January 4, 2018
Boucherville, Quebec
J4B 7K8
Submission Control No.: 211930
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_Sandoz Simvastatin _
_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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMACOLOGY
.............