Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Soliris   
Auth. number : EU/1/07/393
Active substance : Eculizumab
Orphan market exclusivity for "Treatment of paroxysmal nocturnal haemoglobinuria" (based on designation EU/3/03/166) started on 22/06/2007
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 23/07/2015
   This orphan market exclusivity will expire on 22/06/2019
Orphan market exclusivity for "Treatment of atypical haemolytic uremic syndrome" (based on designation EU/3/09/653) started on 29/11/2011
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 23/07/2015
   This orphan market exclusivity will expire on 29/11/2023
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 is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).
- Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
Marketing Authorisation Holder: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, 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 (no change in Commission Decision) EMEA/H/C/791/II/1
08/07/2008 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/791/II/5
03/04/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/791/IB/14
02/06/2009 Centralised - Variation EMEA/H/C/791/II/4, 3 (2009)4320 of 28/05/2009
02/06/2009 Centralised - Variation - Decision addressed to Member States EMEA/H/C/791/II/4, 3 (2009)4319 of 28/05/2009
19/06/2009 Centralised - Notification EMEA/H/C/791/N/15
Updated with Decision(2009)9016 of 11/11/2009
29/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/791/II/12
05/10/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/79/IA/8
22/03/2010 Centralised - Notification EMEA/H/C/791/N/17
Updated with Decision(2010)7078 of 07/10/2010
27/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/791/II/18
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/791/IB/21
28/05/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/791/IB/23
11/10/2010 Centralised - Variation (2010)7078 of 07/10/2010
29/11/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/791/IB/26
28/11/2011 Centralised - Variation - Decision addressed to Member States 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
13/01/2012 Centralised - Variation EMEA/H/C/791/IB/29
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)4272 of 18/06/2012
20/06/2012 Centralised - Renewal EMEA/H/C/791/R/35 (2012)4273 of 18/06/2012
08/10/2012 Centralised - Variation (2012)7101 of 04/10/2012
08/10/2012 Corrigendum (2012)7105 of 04/10/2012
02/05/2013 Centralised - 2-Monthly update 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 - Notification EMEA/H/C/791/N/55
Updated with Decision(2013)9745 of 18/12/2013
23/12/2013 PSUSA - Modification EMEA/H/C/791/PSUV/57 (2013)9745 of 18/12/2013
28/03/2014 Centralised - 2-Monthly update EMEA/H/C/791/II/58/G (2014)2057 of 21/03/2014
20/01/2015 Centralised - Variation EMEA/H/C/791/IAin/73/G
Updated with Decision(2015)2317 of 30/03/2015
10/02/2015 Centralised - Variation EMEA/H/C/791/IA/74
Updated with Decision(2015)2317 of 30/03/2015
01/04/2015 Centralised - 2-Monthly update EMEA/H/C/791/II/66, EMEA/H/C/791/II/71/G (2015)2317 of 30/03/2015
23/07/2015 Centralised - 2-Monthly update EMEA/H/C/791/IB/78 (2015)5215 of 20/07/2015
24/09/2015 Centralised - Variation EMEA/H/C/791/II/77
25/02/2016 Centralised - Variation EMEA/H/C/791/II/81/G
09/06/2016 Centralised - Variation EMEA/H/C/791/IAIN/84/G