An overview of Votubia and why it is authorised in the EU
Votubia is a medicine used to treat the following benign (non-cancerous) tumours caused by the genetic disease tuberous sclerosis:
- subependymal giant cell astrocytoma (SEGA), a benign tumour of the brain, where it is used in adults and children whose brain tumour cannot be surgically removed;
- renal angiomyolipoma, a benign tumour of the kidneys, where it is used in adults who are at risk of complications but who do not require immediate surgery.
The medicine is also used as an add-on treatment in patients from 2 years of age with seizures (fits) related to tuberous sclerosis that have not responded to other treatments. Votubia is used for partial-onset seizures (seizures that start in one part of the brain), which may or may not spread to affect the whole brain (secondary generalisation).
Votubia contains the active substance everolimus.
Tuberous sclerosis is rare, and Votubia was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 August 2010.
Votubia : EPAR - Medicine overview (PDF/90.89 KB)
First published: 19/09/2011
Last updated: 15/06/2018
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Novartis Europharm Limited
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12/07/2018 Votubia - EMEA/H/C/002311 - II/0051
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 201616/12/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 201320/09/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201221/09/2012