Fogilix 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija
Name | Fogilix 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija |
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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 |