Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Esmya   
Auth. number : EU/1/12/750
INN : ulipristal
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03X - Other sex hormones and modulators of the genital system
Chemical subgroup: G03XB - Antiprogestogens
Chemical substance: G03XB02 - Ulipristal
(See WHO ATC Index)
Indication: Ulipristal acetate is indicated for pre operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Marketing Authorisation Holder: Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország

  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
27/02/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2041 (2012)1336 of 23/02/2012
28/02/2012 Centralised - Authorisation EMEA/H/C/2041 (2012)1335 of 23/02/2012
30/07/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2041/T/3 (2012)5477 of 26/07/2012
17/09/2012 Centralised - Variation EMEA/H/C/2041/IB/9
Updated with Decision(2012)7866 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7866 of 29/10/2012
21/02/2013 Centralised - Variation EMEA/H/C/2041/II/12
Updated with Decision(2013)9735 of 18/12/2013
21/03/2013 Centralised - Variation EMEA/H/C/2041/II/13
Updated with Decision(2013)9735 of 18/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/2041/II/14
Updated with Decision(2013)9735 of 18/12/2013
23/12/2013 Centralised - 2-Monthly update EMEA/H/C/2041/II/19 (2013)9735 of 18/12/2013
10/02/2014 Corrigendum (2014)791 of 06/02/2014
14/03/2014 Centralised - Variation EMEA/H/C/2041/IA/22
11/04/2014 Centralised - Variation EMEA/H/C/2041/IA/24