Nixar 2,5 mg/ml oralna otopina
| Name | Nixar 2,5 mg/ml oralna otopina |
|---|---|
| Marketing Authorisation Number | HR-H-467123118 |
| Active Substance | bilastin |
| Composition | jedan ml oralne otopine sadrži 2,5 mg bilastina |
| Pharmaceutical Form | Oralna otopina |
| Manufacturer | Berlin-Chemie AG, Berlin, Njemačka Faes Farma S.A., Derio (Bizkaia), Španjolska |
| Marketing Authorisation Holder | Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, Luksemburg, Luksemburg |
| Marketing Authorisation Date | 14.01.2022 |
| MA Period of Validity | 14.01.2027 |
| Classification Number | UP/I-530-09/19-01/194 |
| Registration Number | 381-12-01/70-22-13 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R06AX29 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
