Votubia

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everolimus

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

Overview

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.

This EPAR was last updated on 04/09/2018

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
OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
02/09/2011
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

12/07/2018 Votubia - EMEA/H/C/002311 - II/0051

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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