Name |
Nixar 20 mg raspadljive tablete za usta |
Marketing Authorisation Number |
HR-H-599781528 |
Active Substance |
bilastin |
Composition |
jedna raspadljiva tableta za usta sadrži 20 mg bilastina |
Pharmaceutical Form |
Raspadljiva tableta za usta |
Manufacturer |
Faes Farma S.A., Leioa (Vizcaya), Španjolska |
Marketing Authorisation Holder |
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, Luksemburg, Luksemburg |
Marketing Authorisation Date |
15.02.2023 |
MA Period of Validity |
15.02.2028 |
Classification Number |
UP/I-530-09/20-01/248 |
Registration Number |
381-12-01/38-23-07 |
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 |
R06AX29 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |