Code | 50812 | ||||||||||
MA number | 21/0187/08-S | ||||||||||
Product Form: | tbl flm 30x100 mg (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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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: | 29.05.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | 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_Topimark 25 50 100 mg_04.2024.pdf |
SPC: | SPC_Topimark_tbl flm_06.2024.pdf |
Safety feature | Yes |
Data update: | 06.11.2018 |