Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Soliris   
Auth. number : EU/1/07/393
INN : Eculizumab
Orphan status based on designation EU/3/03/166 added on 22/06/2007
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA25 - Eculizumab
(See WHO ATC Index)
Indication: Soliris is indicated in adults and children for the treatment of patients with :
  • Paroxysmal nocturnal haemoglobinuria (PNH).

  • Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions.
  • Atypical haemolytic uremic syndrome (aHUS)
Marketing Authorisation Holder: Alexion Europe SAS
25 boulevard de l'Amiral Bruix, F-75016 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
21/06/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/791 (2007)3107 of 20/06/2007
22/06/2007 Centralised - Authorisation EMEA/H/C/791 (2007)3106 of 20/06/2007
19/12/2007 Centralised - Variation EMEA/H/C/791/II/1
08/07/2008 Centralised - Variation EMEA/H/C/791/II/2
05/02/2009 Centralised - Variation EMEA/H/C/791/IB/9
Updated with Decision(2009)4320 of 28/05/2009
03/03/2009 Centralised - Variation EMEA/H/C/791/II/5
03/04/2009 Centralised - Variation EMEA/H/C/791/II/7
07/05/2009 Centralised - Variation EMEA/H/C/791/IA/11
Updated with Decision(2009)9016 of 11/11/2009
28/05/2009 Centralised - Variation EMEA/H/C/791/IB/14
02/06/2009 Centralised - Variation EMEA/H/C/791/II/4, 3 (2009)4319 of 28/05/2009
02/06/2009 Centralised - Variation EMEA/H/C/791/II/4, 3 (2009)4320 of 28/05/2009
19/06/2009 Centralised - Variation EMEA/H/C/791/N/15
Updated with Decision(2009)9016 of 11/11/2009
29/07/2009 Centralised - Variation EMEA/H/C/791/II/12
05/10/2009 Centralised - Variation EMEA/H/C/791/II/16
13/11/2009 Centralised - Variation (2009)9016 of 11/11/2009
23/12/2009 Centralised - Variation EMEA/H/C/791/II/13 (2009)10689 of 21/12/2009
12/01/2010 Centralised - Variation EMEA/H/C/79/IA/8
22/03/2010 Centralised - Variation EMEA/H/C/791/N/17
Updated with Decision(2010)7078 of 07/10/2010
27/04/2010 Centralised - Variation EMEA/H/C/791/II/18
26/05/2010 Centralised - Variation EMEA/H/C/791/IB/21
28/05/2010 Centralised - Variation EMEA/H/C/791/II/19
01/07/2010 Centralised - Variation EMEA/H/C/791/IA/22
Updated with Decision(2010)7078 of 07/10/2010
04/10/2010 Centralised - Variation EMEA/H/C/791/IB/23
11/10/2010 Centralised - Variation (2010)7078 of 07/10/2010
29/11/2010 Centralised - Variation EMEA/H/C/791/II/24
28/03/2011 Centralised - Variation EMEA/H/C/791/II/25 (2011)2082 of 24/03/2011
07/04/2011 Centralised - Variation EMEA/H/C/791/IB/26
28/11/2011 Centralised - Variation EMEA/H/C/791/II/27 (2011)8855 of 24/11/2011
29/11/2011 Centralised - Variation EMEA/H/C/791/II/27 (2011)8856 of 24/11/2011
29/03/2012 Centralised - Variation EMEA/H/C/791/IB/40
Updated with Decision(2012)7101 of 04/10/2012
17/04/2012 Centralised - Variation EMEA/H/C/791/II/38/G (2012)2550 of 13/04/2012
31/05/2012 Referral EMEA/H/C/791/A-20/36 (2012)3581 of 25/05/2012
20/06/2012 Centralised - Renewal EMEA/H/C/791/R/35 (2012)4273 of 18/06/2012
20/06/2012 Centralised - Renewal EMEA/H/C/791/R/35 (2012)4272 of 18/06/2012
08/10/2012 Corrigendum (2012)7105 of 04/10/2012
08/10/2012 Centralised - Variation (2012)7101 of 04/10/2012
02/05/2013 Centralised - Variation EMEA/H/C/791/II/50 (2013)2641 of 29/04/2013
27/06/2013 Centralised - Variation EMEA/H/C/791/II/52/G
Updated with Decision(2013)9745 of 18/12/2013
10/09/2013 Centralised - Variation EMEA/H/C/791/N/55
Updated with Decision(2013)9745 of 18/12/2013
23/12/2013 Centralised - Modification EMEA/H/C/791/PSUV/57 (2013)9745 of 18/12/2013
28/03/2014 Centralised - Variation EMEA/H/C/791/II/58/G (2014)2057 of 21/03/2014