| Code | 8185D | ||||||||||
| MA number | 65/0211/21-S | ||||||||||
| Product Form: | tbl plg 60(2x30)x50 mg (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 29.07.2021 |
| Validity: | 29.07.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Apeneta tablety s predĺženým uvoľňovaním_09.2025.pdf
|
| PIL: |
PIL_Apeneta tablety s predĺženým uvoľňovaním_09.2025.pdf
|
| Safety feature | Yes |
| Data update: | 01.02.2023 |
