Fintepla for DS

Active substance Fenfluramine (as fenfluramine hydrochloride)
Holder UCB PHARMA NV
Status Running
Indication Fintepla for the treatment of patients with Dravet syndrome who completed the open label study ZX008-1900 (EP0215; EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalopathieën” (EudraCT number 2011-004114-42), or the open label study EP0213 (ClinicalTrials.gov ID number NCT06118255) and, in the opinion and the clinical judgement of the treating physician, would continue to benefit from a treatment with Fintepla 2.2 mg/ml oral solution (fenfluramine), which is not yet commercially available in Belgium.
Public documents Approbation
 

Information for the patient

  Informed consent
Last update 03/04/2024

 

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