| Name |
Nixar 6 mg/ml kapi za oko, otopina |
| Marketing Authorisation Number |
HR-H-264633267 |
| Active Substance |
bilastin |
| Composition |
1 ml otopine sadrži 6 mg bilastina. 1 kap sadrži 0,2 mg bilastina. |
| Pharmaceutical Form |
kapi za oko, otopina |
| Manufacturer |
Famar Health Care Services Madrid S.A.U., Alcorcon, Madrid, Španjolska |
| Marketing Authorisation Holder |
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, Luksemburg, Luksemburg |
| Marketing Authorisation Date |
24.08.2022 |
| MA Period of Validity |
24.08.2027 |
| Classification Number |
UP/I-530-09/21-01/100 |
| Registration Number |
381-12-01/38-22-07 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for non-renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
S01GX13 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
