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PRODUCT DETAIL

Fintepla 2.2 mg/ml perorálny roztok

Code 6270D
MA number EU/1/20/1491/003
Product Form: sol por 1x250 ml/550 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 21 - ANTIEPILEPTICA, ANTICONVULSIVA
ATC:
N NERVOUS SYSTEM
N03 ANTIEPILEPTICS
N03A ANTIEPILEPTICS
N03AX Other antiepileptics
N03AX26 Fenfluramine
Shelf life: 48
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 18.12.2020
Validity: 18.12.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 29.12.2020
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