| Active substance | Fenfluramine (as fenfluramine hydrochloride) |
| Holder | UCB PHARMA NV |
| Status | Running |
| Indication | Fintepla for the treatment of patients with Lennox-Gastaut 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 FFA-LGS (EudraCT number 2015-004008-46) 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 |