| Code | 57715 | ||||||||||
| MA number | 21/0076/01-S | ||||||||||
| Product Form: | tbl plg 50x500 mg (vre.papier/Al/PE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | sachet paper/Al/PE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.02.2001 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
DHPC_valproate 22 12 2014.pdf
|
| PIL: |
PIL_Orfiril long_06.2022.pdf
|
| SPC: |
SPC_Orfiril long_06.2022.pdf
|
| Dokument: |
DHPC_Valproát_19.02.2024.pdf
|
| Safety feature | Yes |
| Data update: | 13.05.2020 |
