Name |
Subutex 8 mg sublingvalne tablete |
Marketing Authorisation Number |
HR-H-972538274 |
Active Substance |
buprenorfinklorid |
Composition |
svaka tableta sadrži 8 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-530-09/18-02/34 |
Registration Number |
381-12-01/30-19-08 |
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 |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |