| Code | 6431E | ||||||||||
| MA number | 21/0128/24-S | ||||||||||
| Product Form: | tbl plg 30x165 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Aristo Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 29.06.2024 |
| Validity: | 29.06.2029 |
| PIL: |
PIL_Lusama_07.2024.pdf
|
| SPC: |
SPC_Lusama_07.2024.pdf
|
| Safety feature | Yes |
| Data update: | 02.07.2024 |
