| Code | 61183 | ||||||||||
| MA number | 21/0142/92-S | ||||||||||
| Product Form: | tbl ent 50x150 mg (liek.skl.) | ||||||||||
| 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: | 60 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 07.07.1992 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
DHPC_valproate 22 12 2014.pdf
|
| SPC: |
SPC_Orfiril tbl ent_09.2020.docx
|
| PIL: |
PIL_Orfiril tbl ent_09.2020.docx
|
| 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: | 22.09.2020 |
