| Code | 9508C | ||||||||||
| MA number | 21/0674/96-S | ||||||||||
| Product Form: | plv iol 1x400 mg+1x4 ml solv. (liek.inj.skl.+amp.skl.) | ||||||||||
| 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: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 27.08.1996 |
| Pediatric warnings: | Yes |
| Dokument: |
DHPC_valproate 22 12 2014.pdf
|
| Dokument: |
DHPC_Valproát_19.02.2024.pdf
|
| PIL: |
PIL_Depakine_plv iol_05.2024.pdf
|
| SPC: |
SPC_Depakine plv iol_05.2024.pdf
|
| Safety feature | Yes |
| Data update: | 17.10.2018 |
