| Code | 6269D | ||||||||||
| MA number | EU/1/20/1491/002 | ||||||||||
| Product Form: | sol por 1x120 ml/264 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 |
