CHMP recommends extension of Fintepla indication to include Lennox-Gastaut syndrome
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Fintepla (fenfluramine (oral)
The marketing authorisation holder for this medicinal product is Zogenix ROI Limited/UCB.
The CHMP adopted a new indication to add treatment of seizures associated with Lennox-Gastaut syndrome. For information, the full indications will therefore be as follows: Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
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