Code | 5547D | ||||||||||
MA number | 21/0197/20-S | ||||||||||
Product Form: | tbl ent 100x300 mg (obal PE) | ||||||||||
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: |
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Shelf life: | 60 | ||||||||||
Container: | plastic container | ||||||||||
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 |
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 |
Safety feature | Yes |
Data update: | 22.09.2020 |