Apeneta 50 mg tablete s produljenim oslobađanjem
| Name | Apeneta 50 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-915372093 |
| Active Substance | tapentadolmaleat hemihidrat |
| Composition | jedna tableta s produljenim oslobađanjem sadrži 50 mg tapentadola (u obliku tapentadolmaleata hemihidrata) |
| Pharmaceutical Form | Tableta s produljenim oslobađanjem |
| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija TAD Pharma Gmbh, Cuxhaven, Njemačka |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 03.08.2021 |
| MA Period of Validity | 03.08.2026 |
| Classification Number | UP/I-530-09/20-01/61 |
| Registration Number | 381-12-01/154-21-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to special medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N02AX06 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
