| Code | 3742E | ||||||||||
| MA number | EU/1/23/1732/001 | ||||||||||
| Product Form: | sol inf 5x20 ml/200 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Extrovis EU Ltd., Hungary | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 31.05.2023 |
| Validity: | 31.05.2028 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 07.06.2023 |