Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Votrient   
Auth. number : EU/1/10/628
Active substance : Pazopanib hydrochloride
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE11 - Pazopanib
(See WHO ATC Index)
Indication: Renal cell carcinoma (RCC)
Votrient is indicated in adults for the first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Soft tissue sarcoma (STS)
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS histological tumour subtypes
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
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
16/06/2010 Centralised - Authorisation EMEA/H/C/1141 (2010)4124 of 14/06/2010
19/01/2011 Centralised - Variation EMEA/H/C/1141/IG/34/G
Updated with Decision(2011)3238 Corr of 06/05/2011
03/02/2011 Centralised - Variation EMEA/H/C/1141/II/4 (2011)690 of 01/02/2011
04/05/2011 Centralised - Variation EMEA/H/C/1141/II/1 (2011)3094 of 02/05/2011
12/05/2011 Centralised - Annual renewal EMEA/H/C/1141/R/3 (2011)3238 Corr of 06/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/1141/II/5, 6, 8 (2011)7786 of 24/10/2011
22/03/2012 Centralised - Variation EMEA/H/C/1141/II/9 (2012)1935 of 19/03/2012
25/05/2012 Centralised - Annual renewal EMEA/H/C/1141/R/12 (2012)3457 of 22/05/2012
31/05/2012 Centralised - Variation EMEA/H/C/1141/II/11 (2012)3593 of 25/05/2012
07/08/2012 Centralised - Variation EMEA/H/C/1141/II/7 (2012)5687 of 03/08/2012
04/09/2012 Centralised - Variation EMEA/H/C/1141/II/14 (2012)6153 of 30/08/2012
26/10/2012 Centralised - Variation EMEA/H/C/1141/II/15 (2012)7652 of 24/10/2012
23/11/2012 Corrigendum (2012)8603 of 19/11/2012
13/12/2012 Centralised - Variation EMEA/H/C/1141/II/16/G
Updated with Decision(2013)2744 of 03/05/2013
18/04/2013 Centralised - Variation EMEA/H/C/1141/IG/279
Updated with Decision(2013)4231 of 01/07/2013
07/05/2013 Centralised - 2-Monthly update (2013)2744 of 03/05/2013
18/06/2013 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/1141/R/17 (2013)3868 of 14/06/2013
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/141/II/18 (2013)4231 of 01/07/2013
18/12/2013 Centralised - Variation EMEA/H/C/1141/II/23
Updated with Decision(2015)207 of 15/01/2015
25/09/2014 Centralised - Variation EMEA/H/C/1141/II/25
Updated with Decision(2015)207 of 15/01/2015
20/11/2014 Centralised - Variation EMEA/H/C/1141/II/26
Updated with Decision(2015)207 of 15/01/2015
20/11/2014 Centralised - Variation EMEA/H/C/1141/II/27/G
Updated with Decision(2015)207 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)207 of 15/01/2015
23/04/2015 Centralised - Variation EMEA/H/C/1141/II/29/G
07/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1141/T/30 (2015)3162 of 05/05/2015