TEVA-LEVONORGESTREL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LEVONORGESTREL

Доступна з:

TEVA CANADA LIMITED

Код атс:

G03AD01

ІПН (Міжнародна Ім'я):

LEVONORGESTREL

Дозування:

0.75MG

Фармацевтична форма:

TABLET

Склад:

LEVONORGESTREL 0.75MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

OTC

Терапевтична области:

CONTRACEPTIVES

Огляд продуктів:

Active ingredient group (AIG) number: 0125218002; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2015-11-25

Характеристики продукта

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_Page 1 of 34_
PRODUCT MONOGRAPH
TEVA-LEVONORGESTREL
Levonorgestrel Tablets 0.75 mg
Manufacturer’s Standard
EMERGENCY CONTRACEPTION
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
June 25, 2014
Toronto, Ontario, M1B 2K9
www.tevacanada.com
Submission Control No: 174883
_ _
_Teva-Levonorgestrel- Product Monograph _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH CARE PROVIDER INFORMATION
.......................................... 3
SUMMARY PRODUCT
INFORMATION............................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
.......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
7
DRUG INTERACTIONS
.....................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................. 13
OVERDOSAGE
....................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................ 14
STORAGE AND STABILITY
.............................................................................
17
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................. 17
PART II: SCIENTIFIC INFORMATION
.................................................................. 18
PHARMACEUTICAL INFORMATION
............................................................. 18
CLINICAL TRIALS
.............................................................................................
19
DETAILED PHARMACOLOGY
........................................................................
23
TOXICOLOGY
...............................................................................................