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Votubia (everolimus)

Region

🇪🇺 EU

Active substance

everolimus

Company

Novartis Europharm Limited

Status

Authorised

Therapeutic area

Tuberous Sclerosis

CHMP opinion

Thu 23 Jun 2011

EU approval

Fri 02 Sep 2011

Application

EMEA/H/C/002311

ATC

L01XE10

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Afinitor Authorised · Novartis Europharm Limited

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.