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 14/06/2022

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
Gedeon Richter Plc.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
22/08/2002
Contact address

Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

13/06/2022 Evra - EMEA/H/C/000410 - IB/0051/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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