ellaOne

RSS

ulipristal acetate

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.

This EPAR was last updated on 31/08/2018

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
18
Date of issue of marketing authorisation valid throughout the European Union
15/05/2009
Contact address
5 rue Beranger
F-75003 Paris
France

Product information

22/08/2018 ellaOne - EMEA/H/C/001027 - N/0049

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.

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

How useful was this page?

Add your rating