Code | 7432D | ||||||||||
MA number | 21/0121/21-S | ||||||||||
Product Form: | tbl 30x800 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.06.2021 |
Validity: | 16.06.2026 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Arupsan 800 mg tablety_03.2023.pdf |
SPC: | SPC_Arupsan 800 mg tablety_03.2023.pdf |
Safety feature | Yes |
Data update: | 30.03.2023 |