| Code | 6432E | ||||||||||
| MA number | 21/0129/24-S | ||||||||||
| Product Form: | tbl plg 30x330 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Exeltis Slovakia s.r.o., Slovakia | ||||||||||
| 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_Neudolox_03.2025.pdf
|
| SPC: |
SPC_Neudolox_03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 06.03.2025 |
