Code | 4196E | ||||||||||
MA number | EU/1/23/1743/002 | ||||||||||
Product Form: | sus por 5x110ml/5 500 mg (fľ.HDPE+5 dávk.striek.+ 5 adaptérov) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Marinus Pharmaceuticals Emerald Limited, Ireland | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 26.07.2023 |
Validity: | 26.07.2028 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 21.09.2023 |