| Name |
Subutex 0,4 mg sublingvalne tablete |
| Marketing Authorisation Number |
HR-H-248963307 |
| Active Substance |
buprenorfinklorid |
| Composition |
svaka tableta sadrži 0,4 mg buprenorfina u obliku buprenorfinklorida |
| Pharmaceutical Form |
sublingvalna tableta |
| Manufacturer |
Indivior Europe Limited, Dublin 2, Irska |
| Marketing Authorisation Holder |
Indivior Europe Limited, 27 Windsor Place, Dublin 2, Irska |
| Marketing Authorisation Date |
20.02.2019 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/18-02/32 |
| Registration Number |
381-12-01/30-19-11 |
| 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 |
| Marketing status |
nije stavljeno u promet |
| SmPC |
download |
| PL |
download |