| Code | 8751E | ||||||||||
| MA number | 21/0020/25-S | ||||||||||
| Product Form: | cps dur 90x500 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Billev Pharma ApS, Denmark | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.03.2025 |
| Validity: | 18.03.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Stiripentol Billev cps dur_01.2025.pdf
|
| SPC: |
SPC_Stiripentol Billev cps dur_01.2025.pdf
|
| Safety feature | Yes |
| Data update: | 04.04.2025 |
