Code | 11853 | ||||||||||
MA number | 21/0056/91-S | ||||||||||
Product Form: | tbl flp 30x500 mg (tuba PP) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Sanofi Winthrop Industrie, France | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | tube PP | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 03.10.1991 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
Dokument: | DHPC_valproate 22 12 2014.pdf |
Dokument: | DHPC_Valproát_19.02.2024.pdf |
PIL: | PIL_Depakine Chrono 500 mg_05.2024.pdf |
SPC: | SPC_Depakine Chrono 500 mg_05.2024.pdf |
Dokument: | valproat_Formular o informovani pacientky.pdf |
Dokument: | valproat_Prirucka pre pacienta.pdf |
Dokument: | valproat_Prirucka pre pacientku.pdf |
Dokument: | valproat_Karta pacienta.pdf |
Dokument: | valproat_Prirucka pre zdravotnickych pracovnikov.pdf |
Safety feature | Yes |
Data update: | 17.04.2018 |