Votubia

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everolimus

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 27/06/2022

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
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

24/06/2022 Votubia - EMEA/H/C/002311 - IG/1518

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Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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