Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Votubia   
Auth. number : EU/1/11/710
INN : Everolimus
Orphan status based on designation EU/3/10/764 added on 06/09/2011
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: L01XE10 - Everolimus
(See WHO ATC Index)
Indication: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
The evidence is based on analysis of change in sum of angiomyolipoma volume.
Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.
The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease related symptoms, has not been demonstrated.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
06/09/2011 Centralised - Authorisation EMEA/H/C/2311 (2011)6344 of 02/09/2011
09/02/2012 Centralised - Variation EMEA/H/C/2311/II/1 (2012)767 of 06/02/2012
04/07/2012 Centralised - Variation EMEA/H/C/2311/II/2 (2012)4586 of 28/06/2012
30/07/2012 Centralised - Annual renewal EMEA/H/C/2311/R/5 (2012)5474 of 26/07/2012
06/11/2012 Centralised - Variation EMEA/H/C/2311/II/4 (2012)8006 of 31/10/2012
19/12/2012 Centralised - Variation EMEA/H/C/2311/IB/12
Updated with Decision(2013)4622 of 15/07/2013
17/07/2013 Centralised - Modification EMEA/H/C/2311/PSU/3 (2013)4622 of 15/07/2013
19/07/2013 Centralised - Annual renewal EMEA/H/C/2311/R/15 (2013)4699 of 17/07/2013
07/08/2013 Centralised - Variation EMEA/H/C/2311/N/18
Updated with Decision(2013)8150 of 15/11/2013
19/09/2013 Centralised - Variation EMEA/H/C/2311/II/16/G
Updated with Decision(2013)8150 of 15/11/2013
19/11/2013 Centralised - Variation EMEA/H/C/2311/X/8/G (2013)8150 of 15/11/2013
21/11/2013 Centralised - Variation EMEA/H/C/2311/II/19
Updated with Decision(2014)4271 of 19/06/2014
23/06/2014 Centralised - Modification EMEA/H/C/2311/PSUV/22 (2014)4271 of 19/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/2311/II/20