Rupafin 1 mg/ml oralna otopina
| Name | Rupafin 1 mg/ml oralna otopina |
|---|---|
| Marketing Authorisation Number | HR-H-145923586 |
| Active Substance | rupatadinfumarat |
| Composition | 1 ml oralne otopine sadržava 1 mg rupatadina (u obliku fumarata) |
| Pharmaceutical Form | oralna otopina |
| Manufacturer | Italfarmaco S.A., Alcobendas, Španjolska Noucor Health S.A., Palau-Solita i Plegamans, Barcelona, Španjolska |
| Marketing Authorisation Holder | Noucor Health S.A., Avinguda Del Cami Reial 51-57, Palau-Solita i Plegamans, Barcelona, Španjolska |
| Marketing Authorisation Date | 06.04.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/270 |
| Registration Number | 381-12-01/30-17-02 |
| 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 | R06AX28 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
