Evra

RSS

norelgestromin / ethinyl estradiol

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Evra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Evra.

For practical information about using Evra, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/07/2019

Authorisation details

Product details
Name
Evra
Agency product number
EMEA/H/C/000410
Active substance
  • norelgestromin
  • ethinyl estradiol
International non-proprietary name (INN) or common name
norelgestromin / ethinyl estradiol
Therapeutic area (MeSH)
Contraception
Anatomical therapeutic chemical (ATC) code
G03AA13
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
21/08/2002
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

11/12/2018 Evra - EMEA/H/C/000410 - IAIN/0045

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Female contraception.

Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.

Assessment history

Changes since initial authorisation of medicine

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