FINTEPLA

This brand name is authorized in United States. It is also authorized in Croatia, Estonia, France, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Spain, UK.

Active ingredients

The drug FINTEPLA contains one active pharmaceutical ingredient (API):

1	Fenfluramine UNII 3KC089243P - FENFLURAMINE HYDROCHLORIDE
	Fenfluramine is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome is not known.
	Read more about Fenfluramine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FINTEPLA Oral solution	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
N03AX26		N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics
Discover more medicines within N03AX26

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1835906, 1835917, 1835928, 1835939
ES	Centro de información online de medicamentos de la AEMPS	1201491001
FR	Base de données publique des médicaments	62154820
GB	Medicines & Healthcare Products Regulatory Agency	397999, 398001, 398002
IL	מִשְׂרַד הַבְּרִיאוּת	9014
IT	Agenzia del Farmaco	049286014, 049286026, 049286038, 049286040
JP	医薬品医療機器総合機構	1139016S1020
LT	Valstybinė vaistų kontrolės tarnyba	1091688, 1091689, 1091690, 1091691
PL	Rejestru Produktów Leczniczych	100446075
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68995001, W68995002, W68995003, W68995004
US	FDA, National Drug Code	43376-322