ellaOne

ulipristal acetate

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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.

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

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

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

: 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.

: 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.

List item

ellaOne : EPAR - Summary for the public (PDF/80.06 KB)

First published: 03/06/2009
Last updated: 06/02/2015
- Bulgarian
  (PDF/107.11 KB)
- Croatian
  (PDF/100.41 KB)
- Czech
  (PDF/104.49 KB)
- Danish
  (PDF/80.36 KB)
- Dutch
  (PDF/103.76 KB)
- Estonian
  (PDF/80.3 KB)
- Finnish
  (PDF/102.76 KB)
- French
  (PDF/103.73 KB)
- German
  (PDF/105.12 KB)
- Greek
  (PDF/129.29 KB)
- Hungarian
  (PDF/125.1 KB)
- Italian
  (PDF/102.98 KB)
- Latvian
  (PDF/103.65 KB)
- Lithuanian
  (PDF/198.69 KB)
- Maltese
  (PDF/106.77 KB)
- Polish
  (PDF/129.22 KB)
- Portuguese
  (PDF/103.42 KB)
- Romanian
  (PDF/124.73 KB)
- Slovak
  (PDF/126.87 KB)
- Slovenian
  (PDF/123.91 KB)
- Spanish
  (PDF/103.64 KB)
- Swedish
  (PDF/103.37 KB)

This EPAR was last updated on 25/09/2023

Authorisation details

Product details
Name	ellaOne
Agency product number	EMEA/H/C/001027
Active substance	ulipristal
International non-proprietary name (INN) or common name	ulipristal acetate
Therapeutic area (MeSH)	Contraception, Postcoital
Anatomical therapeutic chemical (ATC) code	G03AD02

Publication details
Marketing-authorisation holder	Laboratoire HRA Pharma
Revision	30
Date of issue of marketing authorisation valid throughout the European Union	15/05/2009
Contact address	200 avenue de Paris 92 320 CHATILLON France

Product information

07/09/2023 ellaOne - EMEA/H/C/001027 - N/0067

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ellaOne: EPAR - Product information (PDF/526.77 KB)

First published: 13/11/2009
Last updated: 19/09/2023
- Bulgarian
  (PDF/648.6 KB)
- Croatian
  (PDF/578.86 KB)
- Czech
  (PDF/696.5 KB)
- Danish
  (PDF/521.36 KB)
- Dutch
  (PDF/568.95 KB)
- Estonian
  (PDF/534.37 KB)
- Finnish
  (PDF/551.57 KB)
- French
  (PDF/535.17 KB)
- German
  (PDF/553.75 KB)
- Greek
  (PDF/621.56 KB)
- Hungarian
  (PDF/623.85 KB)
- Icelandic
  (PDF/536.9 KB)
- Italian
  (PDF/520.91 KB)
- Latvian
  (PDF/593.99 KB)
- Lithuanian
  (PDF/638.17 KB)
- Maltese
  (PDF/621.03 KB)
- Norwegian
  (PDF/564.61 KB)
- Polish
  (PDF/598.72 KB)
- Portuguese
  (PDF/516.68 KB)
- Romanian
  (PDF/574.96 KB)
- Slovak
  (PDF/601.17 KB)
- Slovenian
  (PDF/620.06 KB)
- Spanish
  (PDF/508.66 KB)
- Swedish
  (PDF/508.73 KB)

Other EU languages available icon 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.

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ellaOne: EPAR - All Authorised presentations (PDF/14.11 KB)

First published: 17/07/2009
Last updated: 21/11/2017
- Bulgarian
  (PDF/45.52 KB)
- Croatian
  (PDF/20.98 KB)
- Czech
  (PDF/23.77 KB)
- Danish
  (PDF/15.79 KB)
- Dutch
  (PDF/15.8 KB)
- Estonian
  (PDF/15.7 KB)
- Finnish
  (PDF/16.1 KB)
- French
  (PDF/15.83 KB)
- German
  (PDF/13.35 KB)
- Greek
  (PDF/32.66 KB)
- Hungarian
  (PDF/22.26 KB)
- Icelandic
  (PDF/13.77 KB)
- Italian
  (PDF/16.58 KB)
- Latvian
  (PDF/32.75 KB)
- Lithuanian
  (PDF/34.6 KB)
- Maltese
  (PDF/29.62 KB)
- Norwegian
  (PDF/15.76 KB)
- Polish
  (PDF/21.49 KB)
- Portuguese
  (PDF/17.12 KB)
- Romanian
  (PDF/29.32 KB)
- Slovak
  (PDF/24.98 KB)
- Slovenian
  (PDF/22.27 KB)
- Spanish
  (PDF/16.08 KB)
- Swedish
  (PDF/15.75 KB)

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

List item

ellaOne : EPAR - Procedural steps taken and scientific information after authorisation (PDF/190.99 KB)

First published: 13/11/2009
Last updated: 19/09/2023
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ellaOne-H-C-PSUSA-00003074-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.03 KB)

First published: 21/03/2022
EMA/28536/2022
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ellaOne-H-C-1027-II-0021 : EPAR - Assessment Report - Variation (PDF/2.33 MB)

Adopted

First published: 06/02/2015
Last updated: 06/02/2015
EMA/73099/2015
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CHMP post-authorisation summary of positive opinion for ellaOne (PDF/67.16 KB)

Adopted

First published: 21/11/2014
Last updated: 21/11/2014
EMA/CHMP/717569/2014
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ellaOne-H-C-1027-A31-0028 : EPAR - Assessment Report - Article 31 (PDF/471.4 KB)

Adopted

First published: 24/10/2014
Last updated: 24/10/2014
EMA/464144/2014
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ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/58.23 KB)

First published: 24/10/2014
Last updated: 24/10/2014
- Bulgarian
  (PDF/88.09 KB)
- Croatian
  (PDF/132.63 KB)
- Czech
  (PDF/82.91 KB)
- Danish
  (PDF/54.95 KB)
- Dutch
  (PDF/53.13 KB)
- Estonian
  (PDF/59.75 KB)
- Finnish
  (PDF/56.86 KB)
- French
  (PDF/57.78 KB)
- German
  (PDF/58.99 KB)
- Greek
  (PDF/86.08 KB)
- Hungarian
  (PDF/79.42 KB)
- Italian
  (PDF/56 KB)
- Latvian
  (PDF/80.65 KB)
- Lithuanian
  (PDF/82.02 KB)
- Maltese
  (PDF/83.05 KB)
- Polish
  (PDF/81.72 KB)
- Portuguese
  (PDF/56.52 KB)
- Romanian
  (PDF/79.58 KB)
- Slovak
  (PDF/74.18 KB)
- Slovenian
  (PDF/77.34 KB)
- Spanish
  (PDF/54.32 KB)
- Swedish
  (PDF/57.09 KB)

ellaOne

Table of contents

Overview

ellaOne : EPAR - Summary for the public (PDF/80.06 KB)

Authorisation details

Product information

ellaOne: EPAR - Product information (PDF/526.77 KB)

ellaOne: EPAR - All Authorised presentations (PDF/14.11 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

ellaOne : EPAR - Procedural steps taken and scientific information after authorisation (PDF/190.99 KB)

ellaOne-H-C-PSUSA-00003074-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.03 KB)

ellaOne-H-C-1027-II-0021 : EPAR - Assessment Report - Variation (PDF/2.33 MB)

CHMP post-authorisation summary of positive opinion for ellaOne (PDF/67.16 KB)

ellaOne-H-C-1027-A31-0028 : EPAR - Assessment Report - Article 31 (PDF/471.4 KB)

ellaOne-H-C-1027-A31-0028 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/58.23 KB)

Initial marketing-authorisation documents

ellaOne: EPAR - Public assessment report (PDF/776.46 KB)

Committee for medicinal products for human use summary of positive opinion for Ellaone (PDF/30.29 KB)

News

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