| Code | 5173C | ||||||||||
| MA number | 65/0279/17-S | ||||||||||
| Product Form: | tbl plg 60x40 mg/20 mg (blis.PVC/PVDC/Al-bezpeč.bal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| 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: | 25.09.2017 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Oxycomp tablety s predĺženým uvoľňovaním_10.2024.pdf
|
| PIL: |
PIL_Oxycomp tablety s predĺženým uvoľňovaním_06.2025.pdf
|
| Safety feature | Yes |
| Data update: | 24.02.2022 |
