Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ellaOne   
Auth. number : EU/1/09/522
INN : ulipristal acetate
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03A - Hormonal contraceptives for systemic use
Chemical subgroup: G03AD - Emergency contraceptives
Chemical substance: G03AD02 - Ulipristal
(See WHO ATC Index)
Indication: Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Marketing Authorisation Holder: Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/05/2009 Centralised - Authorisation EMEA/H/C/1027 (2009)4049 of 15/05/2009
27/10/2009 Centralised - Variation EMEA/H/C/1027/II/1 (2009)8380 of 23/10/2009
15/02/2010 Centralised - Variation EMEA/H/C/1027/IA/5
Updated with Decision(2010)3886 of 10/06/2010
25/03/2010 Centralised - Variation EMEA/H/C/1027/IA/4
Updated with Decision(2010)3886 of 10/06/2010
14/06/2010 Centralised - Variation EMEA/H/C/1027/II/6/G (2010)3886 of 10/06/2010
06/07/2010 Centralised - Variation EMEA/H/C/1027/II/2 (2010)4703 of 02/07/2010
10/09/2010 Centralised - Variation EMEA/H/C/1027/IB/8
15/10/2010 Centralised - Variation EMEA/H/C/1027/IA/9
29/11/2010 Centralised - Variation EMEA/H/C/1027/IB/10
15/11/2011 Centralised - Variation EMEA/H/C/1027/II/11/G (2011)8252 of 10/11/2011
20/12/2011 Centralised - Variation EMEA/H/C/1027/IAin/12
Updated with Decision(2012)4579 of 28/06/2012
29/02/2012 Centralised - Variation EMEA/H/C/1027/N/15
Updated with Decision(2012)4579 of 28/06/2012
03/07/2012 Centralised - Variation (2012)4579 of 28/06/2012
08/11/2012 Centralised - Variation EMEA/H/C/1027/N/19
Updated with Decision(2013)9842 of 20/12/2013
16/11/2012 Centralised - Variation EMEA/H/C/1027/II/18
Updated with Decision(2013)9842 of 20/12/2013
16/11/2012 Centralised - Variation EMEA/H/C/1027/II/17
Updated with Decision(2013)9842 of 20/12/2013
22/04/2013 Centralised - Variation EMEA/H/C/1027/IB/22/G
Updated with Decision(2013)9842 of 20/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/1027/II/20
Updated with Decision(2013)9842 of 20/12/2013
02/09/2013 Centralised - Variation EMEA/H/C/1027/N/24
Updated with Decision(2013)9842 of 20/12/2013
20/11/2013 Centralised - Variation EMEA/H/C/1027/N/26
Updated with Decision(2013)9842 of 20/12/2013
24/12/2013 Centralised - Variation (2013)9842 of 20/12/2013
27/01/2014 Centralised - Variation EMEA/H/C/1027/IB/27
26/03/2014 Centralised - Renewal EMEA/H/C/1027/R/25 (2014)2053 of 21/03/2014