Flutiform 250 mikrograma/10 mikrograma po potisku, stlačeni inhalat, suspenzija
Name | Flutiform 250 mikrograma/10 mikrograma po potisku, stlačeni inhalat, suspenzija |
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Marketing Authorisation Number | HR-H-341378137 |
Active Substance | flutikazonpropionat formoterolfumarat dihidrat |
Composition | jedna odmjerena doza (doza koja izlazi iz ventila) sadrži: 250 mikrograma flutikazonpropionata i 10 mikrograma formoterolfumarat dihidrata, što odgovara isporučenoj dozi (dozi koja se oslobađa iz aktivatora) od približno 230 mikrograma flutikazonpropionata i 9 mikrograma formoterolfumarat dihidrata. |
Pharmaceutical Form | stlačeni inhalat, suspenzija |
Manufacturer | Mundipharma DC B.V., Leusden, Nizozemska |
Marketing Authorisation Holder | Mundipharma Gesellschaft m.b.H., Wiedner Gurtel 13, Turm 24, OG 15, Beč, Austrija |
Marketing Authorisation Date | 10.03.2020 |
MA Period of Validity | 10.03.2025 |
Classification Number | UP/I-530-09/19-01/246 |
Registration Number | 381-12-01/70-20-05 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | R03AK11 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |