Name |
Tetmodis 25 mg tablete |
Marketing Authorisation Number |
HR-H-895447033 |
Active Substance |
tetrabenazin |
Composition |
jedna tableta sadrži 25 mg tetrabenazina |
Pharmaceutical Form |
Tableta |
Manufacturer |
AOP Orphan Pharmaceuticals GmbH, Beč, Austrija |
Marketing Authorisation Holder |
AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, Beč, Austrija |
Marketing Authorisation Date |
31.03.2023 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/23-02/16 |
Registration Number |
381-12-01/38-23-04 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
ponovljivi recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
N07XX06 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|