Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Siklos   
Auth. number : EU/1/07/397
Active substance : hydroxycarbamide
Orphan market exclusivity for "Treatment of sickle cell syndrome" (based on designation EU/3/03/154) started on 05/07/2007
   10 years of market exclusivity
   This orphan market exclusivity has ended on 05/07/2017
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX05 - Hydroxycarbamide
(See WHO ATC Index)
Indication: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Syndrome
Marketing Authorisation Holder: Addmedica
101 rue Saint Lazare, F-75009 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
03/07/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/689 (2007)3293 of 29/06/2007
05/07/2007 Centralised - Authorisation EMEA/H/C/689 (2007)3292 of 29/06/2007
09/07/2008 Centralised - Variation EMEA/H/C/689/II/1 (2008)3559 of 07/07/2008
05/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/689/IA/4
05/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/689/IA/2
02/02/2010 Centralised - Variation EMEA/H/C/689/IA/6
Updated with Decision(2010)6324 of 10/09/2010
21/05/2010 Centralised - Notification EMEA/H/C/689/N/7
Updated with Decision(2010)6324 of 10/09/2010
10/08/2010 Centralised - Variation EMEA/H/C/689/IB/8/G
Updated with Decision(2010)6324 of 10/09/2010
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/689/IA/9
14/09/2010 Centralised - Variation (2010)6324 of 10/09/2010
04/10/2010 Centralised - Variation (refusal) EMEA/H/C/689/IA/11
29/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/689/IA/12/G
23/11/2010 Centralised - Variation EMEA/H/C/689/IA/13
Updated with Decision(2011)4810 of 29/06/2011
02/12/2010 Centralised - Variation EMEA/H/C/689/IB/10
03/03/2011 Centralised - Variation EMEA/H/C/689/X/5 (2011)1486 of 28/02/2011
04/03/2011 Centralised - Variation - Decision addressed to Member States EMEA/H/C/689/X/5 (2011)1497 of 28/02/2011
11/05/2011 Centralised - Variation EMEA/H/C/689/IA/16/G
Updated with Decision(2011)4810 of 29/06/2011
31/05/2011 Centralised - Notification EMEA/H/C/689/N/14
Updated with Decision(2011)4810 of 29/06/2011
04/07/2011 Centralised - Variation (2011)4810 of 29/06/2011
07/02/2012 Centralised - Variation EMEA/H/C/689/IA/7/G
Updated with Decision(2012)3215 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3215 of 10/05/2012
03/07/2012 Centralised - Renewal EMEA/H/C/689/R/18 (2012)4566 of 28/06/2012
03/07/2012 Centralised - Renewal EMEA/H/C/689/R/18 (2012)4567 of 28/06/2012
12/10/2012 Centralised - Variation EMEA/H/C/689/IB/19
Updated with Decision(2012)8001 of 31/10/2012
06/11/2012 Centralised - Variation (2012)8001 of 31/10/2012
25/04/2014 PSUSA - Modification EMEA/H/C/689/PSUV/20 (2014)2819 of 23/04/2014
14/07/2014 Centralised - Notification EMEA/H/C/689/N/24
Updated with Decision(2017)2859 of 24/04/2017
26/04/2017 Centralised - Renewal EMEA/H/C/689/R/30 (2017)2859 of 24/04/2017
05/07/2017 Centralised - (orphan status)