| Code | 54238 | ||||||||||
| MA number | 21/0153/00-S | ||||||||||
| Product Form: | sol inj 5x3 ml/300 mg | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Desitin Arzneimitttel GmbH, Germany | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 04.05.2000 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| 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
|
| PIL: |
PIL_Orfiril Injektionslösung_09.2025.pdf
|
| SPC: |
SPC_Orfiril Injektionslösung_09.2025.pdf
|
| Safety feature | Yes |
| Data update: | 14.05.2018 |
