Bupensanduo 8 mg/2 mg sublingvalne tablete
| Name | Bupensanduo 8 mg/2 mg sublingvalne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-413154573 |
| Active Substance | buprenorfinklorid naloksonklorid dihidrat |
| Composition | svaka sublingvalna tableta sadrži 8 mg buprenorfina (u obliku klorida) i 2 mg naloksona (u obliku klorid dihidrata) |
| Pharmaceutical Form | sublingvalna tableta |
| Manufacturer | G.L. Pharma GmbH, Lannach, Austrija |
| Marketing Authorisation Holder | G.L. Pharma GmbH, Schlossplatz 1, Lannach, Austrija |
| Marketing Authorisation Date | 16.06.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/106 |
| Registration Number | 381-12-01/171-23-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | poseban recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N07BC51 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
