| Name |
Buprenorfin Sandoz 8 mg sublingvalne tablete |
| Marketing Authorisation Number |
HR-H-362512961 |
| Active Substance |
buprenorfinklorid |
| Composition |
jedna tableta sadrži 8 mg buprenorfina (u obliku buprenorfinklorida) |
| Pharmaceutical Form |
sublingvalna tableta |
| Manufacturer |
Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder |
Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date |
05.03.2018 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/17-02/136 |
| Registration Number |
381-12-01/30-18-05 |
| 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 |
N07BC01 |
| SmPC |
download |
| PL |
download |