| Code | 0100F | ||||||||||
| MA number | 21/0191/25-S | ||||||||||
| Product Form: | cps dur 200x400 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.05.2025 |
| Validity: | 28.05.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Gabapentin Teva B.V._05.2025.pdf
|
| PIL: |
PIL_Gabapentin Teva B.V._05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 29.05.2025 |
