ellaOne

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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 16/11/2022

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
26
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

08/11/2022 ellaOne - EMEA/H/C/001027 - N/0063

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:

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

  • 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

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