| Code | 36736 | ||||||||||
| MA number | 21/0429/06-S | ||||||||||
| Product Form: | tbl plg 90x500 mg (blis.Al/PVC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | ratiopharm GmbH, Germany | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 05.10.2006 |
| 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_Valpro ratiopharm Chrono_500 mg_09.2024.pdf
|
| SPC: |
SPC_Valpro ratiopharm Chrono_500 mg_09.2024.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: | 05.06.2018 |
