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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Esmya   
Auth. number : EU/1/12/750
INN : ulipristal
ATC: Pending
Indication: Ulipristal acetate is indicated for pre operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The duration of treatment is limited to 3 months.
Marketing Authorisation Holder: Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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
21/03/2013 Centralised - Variation EMEA/H/C/2041/II/13