| Code | 6424C | ||||||||||
| MA number | 65/0392/17-S | ||||||||||
| Product Form: | tbl plg 98x10 mg/5 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| 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: | 20.12.2017 |
| SPC: |
SPC_Oxykodon_Naloxon Mylan tablety s predĺženým uvoľňovaním_06.2023.pdf
|
| PIL: |
PIL_Oxykodon_Naloxon Mylan tablety s predĺženým uvoľňovaním_06.2023.pdf
|
| Safety feature | Yes |
| Data update: | 18.01.2021 |
