| Code | 41194 | ||||||||||
| MA number | 21/0120/11-S | ||||||||||
| Product Form: | tbl flm 60x50 mg (blis.Al/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 05.03.1998 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Dokument: |
DHPC_Topiramát_obmedzenia na zabránenie expozicie topiramátu počas tehot....pdf
|
| PIL: |
PIL_Topamax tbl flm_04.2024.pdf
|
| SPC: |
SPC_Topamax tbl flm_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 28.02.2018 |
