SANDOZ LOVASTATIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LOVASTATIN

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

C10AA02

ІПН (Міжнародна Ім'я):

LOVASTATIN

Дозування:

20MG

Фармацевтична форма:

TABLET

Склад:

LOVASTATIN 20MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/500

Тип рецепту:

Prescription

Терапевтична области:

HMG-COA REDUCTASE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0120669002; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2019-08-01

Характеристики продукта

_ _
_Sandoz Lovastatin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR SANDOZ LOVASTATIN
Lovastatin Tablets USP
20 mg and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision: March 20, 2014
Submission Control Number: 172518
_ _
_Sandoz Lovastatin _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOGY
............................................