NORLEVO TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LEVONORGESTREL

Предлага се от:

LABORATOIRE HRA PHARMA

АТС код:

G03AD01

INN (Международно Name):

LEVONORGESTREL

дозиране:

0.75MG

Лекарствена форма:

TABLET

Композиция:

LEVONORGESTREL 0.75MG

Начин на приложение:

ORAL

Броя в опаковка:

2

Вид предписание :

OTC

Терапевтична област:

CONTRACEPTIVES

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2017-01-31

Данни за продукта

_ _
_Appendix E - Product Monograph Template - Standard _
_Page 1 of 35_
PRODUCT MONOGRAPH
NORLEVO
®
LEVONORGESTREL TABLETS
0.75 MG
MANUFACTURER’S STANDARD
EMERGENCY CONTRACEPTION
Manufacturer :
Laboratoire HRA Pharma
15, rue Béranger
75003, Paris, France
Date of Revision:
March 14, 2014
Distributor :
Bayer Inc
77 Belfield Road
Toronto, Ontario, M9W 1G6
Canada
Date of Approval:
March 19, 2014
_ _
Submission Control No: 170655
_ _
_Appendix E - Product Monograph Template - Standard _
_Page 2 of 35_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATION
........................................................................