Code | 6268D | ||||||||||
MA number | EU/1/20/1491/001 | ||||||||||
Product Form: | sol por 1x60 ml/132 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | UCB Pharma S.A. , Belgium | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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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 |
Dokument: | Fintepla_Príručka pre pacienta.pdf |
Dokument: | Fintepla_Príručka pre lekára.pdf |
Safety feature | Yes |
Data update: | 03.02.2023 |