Fogilix 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija
| Name | Fogilix 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija |
|---|---|
| Marketing Authorisation Number | HR-H-805271839 |
| Active Substance | azelastinklorid flutikazonpropionat |
| Composition | 1 ml spreja za nos, suspenzije sadrži 1000 mikrograma azelastinklorida i 365 mikrograma flutikazonpropionata. Jednim potiskom (0,14 g) oslobađa se 137 mikrograma azelastinklorida (125 mikrograma azelastina) i 50 mikrograma flutikazonpropionata |
| Pharmaceutical Form | sprej za nos, suspenzija |
| Manufacturer | Teva Czech Industries s.r.o., Opava, Češka
Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 22.09.2023 |
| MA Period of Validity | 22.09.2028 |
| Classification Number | UP/I-530-09/22-01/128 |
| Registration Number | 381-12-01/171-23-08 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | R01AD58 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
