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 | Faes Farma S.A., Leioa (Vizcaya), Španjolska
Berlin-Chemie AG, Berlin, Njemačka |
| 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 | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | R06AX29 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
