Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 27 June 2018

Indication(s)

- Votubia 2.5 mg tablets
- Votubia 5 mg tablets
- Votubia 10 mg tablets:


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.

 

- Votubia 2 mg dispersible tablets
- Votubia 3 mg dispersible tablets
- Votubia 5 mg dispersible tablets:


Refractory seizures associated with tuberous sclerosis complex (TSC)
Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).

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.

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More information

Category Value
Agency product number EMEA/H/C/002311
Orphan designation Yes
Date First Approved 02-09-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Novartis Europharm Limited
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions