Evra

norelgestromin / ethinyl estradiol

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Evra?

Evra is a transdermal patch (a patch that delivers a medicine across the skin). It contains two active substances: norelgestromin (6 mg) and ethinyl estradiol (600 micrograms).

What is Evra used for?

Evra is a female contraceptive. Evra is intended for women of fertile age. Its safety and effectiveness have been studied in women aged 18 to 45 years.

The medicine can only be obtained with a prescription.

How is Evra used?

Evra is used as one patch per week for three weeks, followed by a fourth week, which is patch-free. Patches must always be applied regularly, on the same day of the week. The first patch is applied on day 1, and then changed on day 8. The second patch is then changed on day 15. The patch-free interval starts on day 22 and lasts for seven days. The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms. The effectiveness of Evra may be lower in women weighing over 90 kg.

The patch must be firmly applied to the buttock, abdomen (tummy), upper arm or upper back, but not on the breast, or on skin that is red, irritated or cut. The same area of skin should not be used for two consecutive patches. When a patch is taken off, it is important that it is discarded appropriately. The pack has a special device for the patient to stick the old patch before discarding. For full instructions on how to use Evra, see the package leaflet.

How does Evra work?

Evra is a patch version of 'the pill' (combined oral contraceptive pill). Using a weekly patch instead of a daily pill may help the patient to stick to using her contraception appropriately. The active substances in Evra are two hormones, ethinyl estradiol (an oestrogen) and norelgestromin (a progestogen). Ethinyl estradiol has been in use extensively in oral contraceptives for many years, and norelgestromin is very similar to another progestogen, which is also used in some oral contraceptives. Evra works like the pill by changing the body’s hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).

How has Evra been studied?

Evra has been studied in three main studies in over 3,000 women. In two studies, Evra was compared with combined oral contraceptives: in one study, the comparator was a 'monophasic' contraceptive (pills containing constant amounts of the active substances over the first three weeks of the treatment cycle) and in the other study, they were 'triphasic' (with the amount of the active substances in the pills varying through the treatment cycle). The third study did not compare Evra with any other medicine. All of the studies lasted for a year (13 four-week cycles). The main measure of effectiveness was the number of women who became pregnant.

What benefit has Evra shown during the studies?

Overall in the three studies, 15 pregnancies occurred in women taking Evra, 12 of which were the result of a 'method failure' (when a pregnancy occurs despite the contraceptive being used correctly). This gives Evra a 'Pearl Index' of 0.90. The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 woman-years (corresponding to 1,300 cycles). The Pearl Indices for the oral contraceptives were 0.57 (monophasic) and 1.28 (triphasic). Five of the pregnancies were in women weighing over 90 kg.

What is the risk associated with Evra?

During the studies, the most common side effects with Evra (seen in more than 1 patient in 10) were headache, nausea (feeling sick) and breast tenderness. For the full list of all side effects reported with Evra, see the package leaflet.

Evra should not be used by women who may be hypersensitive (allergic) to norelgestromin, ethinyl estradiol or any of the other ingredients. It should not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels, high cholesterol levels, or a family history of thrombosis). It should not be used in women who have migraine with aura (visual or other symptoms), some types of cancer or abnormal bleeding from the genital area whose cause has not been diagnosed. For the full list of restrictions, see the package leaflet.

Why has Evra been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Evra’s benefits are greater than its risks for female contraception. The Committee recommended that Evra be given marketing authorisation.

Other information about Evra

The European Commission granted a marketing authorisation valid throughout the European Union for Evra to Janssen-Cilag International N.V. on 22 August 2002. The marketing authorisation was renewed on 22 August 2007.

Name Language First published Last updated
Evra : EPAR - Summary for the public BG = bălgarski 2008-08-05  
Evra : EPAR - Summary for the public ES = español 2008-08-05  
Evra : EPAR - Summary for the public CS = čeština 2008-08-05  
Evra : EPAR - Summary for the public DA = dansk 2008-08-05  
Evra : EPAR - Summary for the public DE = Deutsch 2008-08-05  
Evra : EPAR - Summary for the public ET = eesti keel 2008-08-05  
Evra : EPAR - Summary for the public EL = elliniká 2008-08-05  
Evra : EPAR - Summary for the public EN = English 2008-08-05  
Evra : EPAR - Summary for the public FR = français 2008-08-05  
Evra : EPAR - Summary for the public IT = italiano 2008-08-05  
Evra : EPAR - Summary for the public LV = latviešu valoda 2008-08-05  
Evra : EPAR - Summary for the public LT = lietuvių kalba 2008-08-05  
Evra : EPAR - Summary for the public HU = magyar 2008-08-05  
Evra : EPAR - Summary for the public MT = Malti 2008-08-05  
Evra : EPAR - Summary for the public NL = Nederlands 2008-08-05  
Evra : EPAR - Summary for the public PL = polski 2008-08-05  
Evra : EPAR - Summary for the public PT = português 2008-08-05  
Evra : EPAR - Summary for the public RO = română 2008-08-05  
Evra : EPAR - Summary for the public SK = slovenčina 2008-08-05  
Evra : EPAR - Summary for the public SL = slovenščina 2008-08-05  
Evra : EPAR - Summary for the public FI = suomi 2008-08-05  
Evra : EPAR - Summary for the public SV = svenska 2008-08-05  

This EPAR was last updated on 27/05/2016 .

Authorisation details

Product details

Product details for Evra
NameEvra
Agency product numberEMEA/H/C/000410
Active substance

norelgestromin / ethinyl estradiol

International non-proprietary name (INN) or common name

norelgestromin / ethinyl estradiol

Therapeutic area Contraception
Anatomical therapeutic chemical (ATC) code G03AA13

Publication details

Publication details for Evra
Marketing-authorisation holder

Janssen-Cilag International NV

Revision17
Date of issue of marketing authorisation valid throughout the European Union22/08/2002

Contact address:

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

Product information

14/04/2016  Evra -EMEA/H/C/000410 -II/0039

Name Language First published Last updated
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27
Evra : EPAR - Product Information SV = svenska 2009-04-06 2016-05-27

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06
Evra : EPAR - All Authorised presentations SV = svenska 2005-10-21 2009-04-06

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

Name Language First published Last updated
Evra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-04-06 2016-05-27
Evra-H-C-410-A31-1356 : EPAR - Assessment Report - Article 31 SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions SV = svenska 2014-04-08  
Evra : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2005-10-21  

Initial marketing-authorisation documents

Name Language First published Last updated
Evra : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21  
Evra : EPAR - Scientific Discussion SV = svenska 2005-10-21  

Authorised

This medicine is approved for use in the European Union

More information on Evra