31 January 2017 - Decision marks the third TSC-related indication for Votubia in the EU, where it is also approved to treat SEGA and renal angiomyolipomas.
Novartis today announced that the European Commission has approved Votubia (everolimus) dispersible tablets as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).
Votubia is now the first approved pharmacologic therapy in all 28 member states of the European Union (EU), plus Iceland and Norway, specifically for the treatment of refractory partial-onset seizures associated with TSC.