| 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: |
|
||||||||||
| 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
|
| Dokument: |
valproat_Prirucka pre zdravotnickych pracovnikov_interaktivna.pdf
|
| Dokument: |
valproat_Prirucka pre pacientku_interaktivna.pdf
|
| Safety feature | Yes |
| Data update: | 17.04.2018 |
