Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Nexavar   
Auth. number : EU/1/06/342
Active substance : Sorafenib
Orphan market exclusivity for "Treatment of renal cell carcinoma" (based on designation EU/3/04/207) started on 21/07/2006
   10 years of market exclusivity
   This orphan market exclusivity has ended on 22/07/2016
Orphan market exclusivity for "Treatment of hepatocellular carcinoma" (based on designation EU/3/06/364) started on 31/10/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 31/10/2017
Orphan market exclusivity for "Treatment of follicular thyroid cancer" (based on designation EU/3/13/1199) started on 27/05/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/05/2024
Orphan market exclusivity for "Treatment of papillary thyroid cancer" (based on designation EU/3/13/1200) started on 27/05/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/05/2024
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE05 - Sorafenib
(See WHO ATC Index)
Indication: Hepatocellular carcinoma
Nexavar is indicated for the treatment of hepatocellular carcinoma.
Renal cell carcinoma
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Differentiated thyroid carcinoma
Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Marketing Authorisation Holder: Bayer AG
D-51368 Leverkusen, Deutschland
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
21/07/2006 Centralised - Authorisation EMEA/H/C/690 (2006)3362 of 19/07/2006
09/01/2007 Centralised - Variation EMEA/H/C/690/II/1 (2007)18 of 03/01/2007
26/01/2007 Centralised - Variation EMEA/H/C/690/II/2 (2007)264 of 24/01/2007
23/08/2007 Centralised - Variation EMEA/H/C/690/II/4 (2007)4018 of 21/08/2007
31/10/2007 Centralised - Variation EMEA/H/C/690/II/5, 6, 7 (2007)5369 of 29/10/2007
22/04/2008 Centralised - Variation EMEA/H/C/690/II/8 (2008)1631 of 18/04/2008
10/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/690/IA/9
27/11/2008 Centralised - Variation EMEA/H/C/690/II/10 (2008)7601 of 25/11/2008
04/03/2009 Centralised - Variation EMEA/H/C/690/II/11 (2009)1580 of 02/03/2009
18/03/2009 Centralised - Variation EMEA/H/C/690/IA/14
Updated with Decision(2009)2870 of 07/04/2009
09/04/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/690/T/13 (2009)2870 of 07/04/2009
10/06/2009 Corrigendum EMEA/H/C/690/T/13 (2009)2870 of 08/06/2009
30/07/2009 Centralised - Variation EMEA/H/C/690/II/12 (2009)6064 of 24/07/2009
19/10/2009 Centralised - Variation EMEA/H/C/690/II/15 (2009)8073 of 15/10/2009
25/11/2009 Centralised - Variation EMEA/H/C/690/II/16 (2009)9443 of 23/11/2009
19/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/690/IB/17
21/06/2010 Centralised - Variation EMEA/H/C/690/IG/9/G
Updated with Decision(2010)6002 of 26/08/2010
02/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/690/IB/20
03/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/690/IA/19
30/08/2010 Centralised - Variation EMEA/H/C/690/II/18/G (2010)6002 of 26/08/2010
02/09/2010 Centralised - Variation EMEA/H/C/690/IB/21/G
Updated with Decision(2010)8537 of 26/11/2010
22/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/690/IB/23/G
01/12/2010 Centralised - Variation EMEA/H/C/690/II/22/G (2010)8537 of 26/11/2010
19/01/2011 Centralised - Variation EMEA/H/C/690/IA/25/G
Updated with Decision(2011)2698 of 12/04/2011
14/04/2011 Centralised - Variation (2011)2698 of 12/04/2011
04/05/2011 Centralised - Variation EMEA/H/C/690/II/26/G (2011)3086 of 02/05/2011
05/07/2011 Centralised - Renewal EMEA/H/C/690/R/24 (2011)4841 of 29/06/2011
02/08/2011 Centralised - Variation EMEA/H/C/690/II/27 (2011)5698 of 01/08/2011
16/08/2011 Centralised - Variation EMEA/H/C/690/IA/29/G
Updated with Decision(2011)7787 of 24/10/2011
26/10/2011 Centralised - Variation EMEA/H/C/690/II/28 (2011)7787 of 24/10/2011
11/01/2012 Centralised - Variation EMEA/H/C/690/IB/31/G
Updated with Decision(2012)4499 of 27/06/2012
02/07/2012 Centralised - Variation EMEA/H/C/690/II/32 (2012)4499 of 27/06/2012
21/02/2013 Centralised - Variation EMEA/H/C/690/II/34/G
Updated with Decision(2014)640 of 31/01/2014
17/01/2014 Centralised - Notification EMEA/H/C/690/N/36
Updated with Decision(2014)640 of 31/01/2014
04/02/2014 Centralised - Yearly update (2014)640 of 31/01/2014
27/05/2014 Centralised - 2-Monthly update EMEA/H/C/690/II/35 (2014)3623 of 23/05/2014
25/11/2014 PSUSA - Modification EMEA/H/C/690/PSUV/37 (2014)9037 of 21/11/2014
22/07/2016 Centralised - (orphan status)
02/09/2016 Centralised - Notification EMEA/H/C/690/N/38
Updated with Decision(2017)4937 of 06/07/2017
16/03/2017 Centralised - Variation EMEA/H/C/690/IAIN/39/G
Updated with Decision(2017)4937 of 06/07/2017
10/07/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/690/T/42 (2017)4937 of 06/07/2017