OVRAL 21 TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NORGESTREL (NORGESTREL); ETHINYL ESTRADIOL

Предлага се от:

PFIZER CANADA ULC

АТС код:

G03AA06

INN (Международно Name):

NORGESTREL AND ESTROGEN

дозиране:

250MCG; 50MCG

Лекарствена форма:

TABLET

Композиция:

NORGESTREL (NORGESTREL) 250MCG; ETHINYL ESTRADIOL 50MCG

Начин на приложение:

ORAL

Броя в опаковка:

21

Вид предписание :

Prescription

Терапевтична област:

CONTRACEPTIVES

Каталог на резюме:

Active ingredient group (AIG) number: 0231284001; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2010-09-30

Данни за продукта

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PRODUCT MONOGRAPH
Pr
OVRAL® 21
Norgestrel and Ethinyl Estradiol Tablets
250 μg of d-norgestrel supplied as 500 μg norgestrel (dl-racemate)
and 50 μg ethinyl estradiol
USP
Oral Contraceptive
®T.M. Wyeth
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
November 3, 2010
Submission Control No: 140336
©
Pfizer Canada Inc.
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_Page 2 of 53_
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..................................................................................................13
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND
ADMINISTRATION..............................................................................25
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................29
STORAGE AND
STABILITY..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................32
PHARMACEUTICAL
INFORMATION.................................................