Code | 55880 | ||||||||||
MA number | 21/0121/11-S | ||||||||||
Product Form: | tbl flm 100x100 mg (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Johnson & Johnson, s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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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 |
Dokument: | Topiramát_Príručka pre zdravotníckych pracovníkov.pdf |
Dokument: | Topiramát_Príručka pre pacientku.pdf |
Dokument: | Topiramát_Formulár informovanosti o rizikách.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 |