| Code | 83246 | ||||||||||
| MA number | 21/0755/09-S | ||||||||||
| Product Form: | tbl flm 10x25 mg (fľ.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| 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 10(1) generic application |
| MA issued: | 30.11.2009 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
DHPC_Topiramát_obmedzenia na zabránenie expozicie topiramátu počas tehot....pdf
|
| Dokument: |
Topiramát_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Topiramát_Príručka pre pacientku.pdf
|
| Dokument: |
Topiramát_Formulár informovanosti o rizikách.pdf
|
| PIL: |
PIL_Talopam_04.2024.pdf
|
| SPC: |
SPC_Talopam_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 07.05.2018 |
