Evra
norelgestromin / ethinyl estradiol
Table of contents
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.
Authorisation details
Product details | |
---|---|
Name |
Evra
|
Agency product number |
EMEA/H/C/000410
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Contraception
|
Anatomical therapeutic chemical (ATC) code |
G03AA13
|
Publication details | |
---|---|
Marketing-authorisation holder |
Gedeon Richter Plc.
|
Revision |
25
|
Date of issue of marketing authorisation valid throughout the European Union |
22/08/2002
|
Contact address |
Gyomroi ut 19-21 |
Product information
09/11/2022 Evra - EMEA/H/C/000410 - IB/0053
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.