Votubia
everolimus
Table of contents
Overview
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.
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List item
Votubia : EPAR - Medicine overview (PDF/90.89 KB)
First published: 19/09/2011
Last updated: 15/06/2018
EMA/528406/2011 -
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List item
Votubia : EPAR - Risk-management-plan summary (PDF/81.17 KB)
First published: 12/02/2020
Last updated: 21/06/2021
Authorisation details
Product details | |
---|---|
Name |
Votubia
|
Agency product number |
EMEA/H/C/002311
|
Active substance |
everolimus
|
International non-proprietary name (INN) or common name |
everolimus
|
Therapeutic area (MeSH) |
Tuberous Sclerosis
|
Anatomical therapeutic chemical (ATC) code |
L01XE10
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
30
|
Date of issue of marketing authorisation valid throughout the European Union |
02/09/2011
|
Contact address |
Vista Building |
Product information
24/06/2022 Votubia - EMEA/H/C/002311 - IG/1518
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic 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.