| Code | 52886 | ||||||||||
| MA number | 21/0401/08-S | ||||||||||
| Product Form: | tbl flm 30x 50 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.08.2008 |
| Dokument: |
DHPC_Topiramát_obmedzenia na zabránenie expozicie topiramátu počas tehot....pdf
|
| PIL: |
PIL_Topilex_12.2023.pdf
|
| SPC: |
SPC_Topilex_12.2023.pdf
|
| Dokument: |
Topiramát_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Topiramát_Príručka pre pacientku.pdf
|
| Dokument: |
Topiramát_Formulár informovanosti o rizikách.pdf
|
| Safety feature | Yes |
| Data update: | 10.04.2018 |
