ellaOne

ulipristal acetate

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This is a summary of the European public assessment report (EPAR) for ellaOne. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ellaOne.

What is ellaOne?

EllaOne is a medicine that contains the active substance ulipristal acetate. It is available as tablets (30 mg).

What is ellaOne used for?

EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).

The medicine can be obtained without a prescription.

How is ellaOne used?

EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure. If the woman vomits within three hours of taking the medicine she should take another tablet. EllaOne can be taken at any time during the menstrual cycle.

If a woman’s menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before ellaOne is taken.

How does ellaOne work?

For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb. The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.

The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator. This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect. Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation. If ovulation has already occurred, ellaOne is no longer effective.

How has ellaOne been studied?

In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure. The main measure of effectiveness was the number of women who did not become pregnant. This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive. This number was calculated from published pregnancy rates.

An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception). This study included women who took the medicine within two days of unprotected sex or contraceptive failure.

What benefit has ellaOne shown during the studies?

EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies. Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant. This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive. EllaOne therefore prevented about three-fifths of the pregnancies.

The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne. In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.

What is the risk associated with ellaOne?

The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains). For the full list of all side effects and restrictions, see the package leaflet.

Why has ellaOne been approved?

The CHMP decided that ellaOne’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of ellaOne?

A risk management plan has been developed to ensure that ellaOne is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about ellaOne

The European Commission granted a marketing authorisation valid throughout the European Union for ellaOne on 15 May 2009.

For more information about treatment with ellaOne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
ellaOne : EPAR - Summary for the public BG = bălgarski 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public ES = español 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public CS = čeština 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public DA = dansk 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public DE = Deutsch 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public ET = eesti keel 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public EL = elliniká 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public EN = English 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public FR = français 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public IT = italiano 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public LV = latviešu valoda 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public LT = lietuvių kalba 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public HU = magyar 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public MT = Malti 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public NL = Nederlands 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public PL = polski 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public PT = português 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public RO = română 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public SK = slovenčina 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public SL = slovenščina 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public FI = suomi 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public SV = svenska 03/06/2009 06/02/2015
ellaOne : EPAR - Summary for the public HR = Hrvatski 03/06/2009 06/02/2015

This EPAR was last updated on 05/06/2015 .

Authorisation details

Product details

Product details for ellaOne
NameellaOne
Agency product numberEMEA/H/C/001027
Active substance

ulipristal

International non-proprietary name (INN) or common name

ulipristal acetate

Therapeutic area Contraception, Postcoital
Anatomical therapeutic chemical (ATC) code G03AD02

Publication details

Publication details for ellaOne
Marketing-authorisation holder

Laboratoire HRA Pharma

Revision12
Date of issue of marketing authorisation valid throughout the European Union15/05/2009

Contact address:

Laboratoire HRA Pharma
5 rue Beranger
F-75003 Paris
France

Product information

Product information

23/04/2015  ellaOne -EMEA/H/C/001027 -II/0037

Name Language First published Last updated
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015
ellaOne: EPAR - Product Information HR = Hrvatski 13/11/2009 05/06/2015

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
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010
ellaOne: EPAR - All Authorised presentations HR = Hrvatski 17/07/2009 23/07/2010

Pharmacotherapeutic group

Sex hormones and modulators of the genital system, emergency contraceptives

Therapeutic indication

Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ellaOne : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 13/11/2009 05/06/2015
ellaOne-H-C-1027-II-0021 : EPAR - Assessment Report - Variation HR = Hrvatski 06/02/2015  
CHMP post-authorisation summary of positive opinion for ellaOne HR = Hrvatski 21/11/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Assessment Report - Article 31 HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  
ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 24/10/2014  

Initial marketing-authorisation documents

Name Language First published Last updated
ellaOne: EPAR - Public assessment report HR = Hrvatski 03/06/2009  
Committee for medicinal products for human use summary of positive opinion for Ellaone HR = Hrvatski 18/03/2009  

Authorised

This medicine is approved for use in the European Union