This brand name is authorized in Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States
The drug FINTEPLA contains one active pharmaceutical ingredient (API):
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1
Fenfluramine
UNII 3KC089243P - FENFLURAMINE HYDROCHLORIDE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| FINTEPLA Oral solution | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| N03AX26 | N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1835906, 1835917, 1835928, 1835939 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1201491001 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 62154820 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 397999, 398001, 398002 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 9014 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 049286014, 049286026, 049286038, 049286040 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 1139016S1020 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1091688, 1091689, 1091690, 1091691 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100446075 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68995001, W68995002, W68995003, W68995004 |
| Country: US | FDA, National Drug Code | Identifier(s): 43376-322 |
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