Flutiform 125 mikrograma/5 mikrograma po potisku, stlačeni inhalat, suspenzija
| Name | Flutiform 125 mikrograma/5 mikrograma po potisku, stlačeni inhalat, suspenzija |
|---|---|
| Marketing Authorisation Number | HR-H-702532961 |
| Active Substance | flutikazonpropionat formoterolfumarat dihidrat |
| Composition | jedna odmjerena doza (doza koja izlazi iz ventila) sadrži: 125 mikrograma flutikazonpropionata i 5 mikrograma formoterolfumarat dihidrata, što odgovara isporučenoj dozi (dozi koja se oslobađa iz aktivatora) od približno 115 mikrograma flutikazonpropionata i 4,5 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 | 27.08.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/47 |
| Registration Number | 381-12-01/70-24-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R03AK11 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
