ORTHO 7/7/7 TABLETS (28 DAY)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NORETHINDRONE; ETHINYL ESTRADIOL; NORETHINDRONE; ETHINYL ESTRADIOL; NORETHINDRONE; ETHINYL ESTRADIOL

Предлага се от:

JANSSEN INC

АТС код:

G03AB04

INN (Международно Name):

NORETHISTERONE AND ESTROGEN

дозиране:

0.5MG; 0.035MG; 0.75MG; 0.035MG; 1MG; 0.035MG

Лекарствена форма:

TABLET

Композиция:

NORETHINDRONE 0.5MG; ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.75MG; ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG; ETHINYL ESTRADIOL 0.035MG

Начин на приложение:

ORAL

Броя в опаковка:

12X1/28

Вид предписание :

Prescription

Терапевтична област:

CONTRACEPTIVES

Каталог на резюме:

Active ingredient group (AIG) number: 0616240002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2017-09-01

Данни за продукта

_201105 ORTHO 7-7-7 _APM.doc _
_EDMS-ERI-134831445 v5.0 _
_Page 1 of 61 _
PRODUCT MONOGRAPH
PR
ORTHO
® 7/7/7
norethindrone and ethinyl estradiol Tablets, USP
0.5 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
0.75 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
1.0 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
Oral Contraceptive
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 14, 2017
SUBMISSION CONTROL NO.: 201105
© 2017 Janssen Inc.
All trademarks used under license.
_201105 ORTHO 7-7-7 _APM.doc _
_EDMS-ERI-134831445 v5.0 _
_Page 2 of 61 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 27
STORAGE AND STABILITY
.................................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................