Aforbe 100/6 mikrograma po potisku, stlačeni inhalat, otopina
| Name | Aforbe 100/6 mikrograma po potisku, stlačeni inhalat, otopina |
|---|---|
| Marketing Authorisation Number | HR-H-586836848 |
| Active Substance | beklometazondipropionat formoterolfumarat dihidrat |
| Composition | jedna odmjerena doza (potiskom preko ventila) sadrži 100 mikrograma beklometazondipropionata i 6 mikrograma formoterolfumarat dihidrata. To odgovara isporučenoj dozi (preko nastavka za usta) od 84,6 mikrograma beklometazondipropionata i 5,0 mikrograma formoterolfumarat dihidrata |
| Pharmaceutical Form | Stlačeni inhalat, otopina |
| Manufacturer | McDermott Laboratories Limited, t/a Mylan Dublin Respiratory, Dublin 13, Irska Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka Eurofins BioPharma Product Testing Finland Oy, Kuopio, Finska Eurofins BioPharma Product Testing Finland Oy, Kuopio, Finska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 24.08.2022 |
| MA Period of Validity | 24.08.2027 |
| Classification Number | UP/I-530-09/20-01/242 |
| Registration Number | 381-12-01/70-22-08 |
| 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 | R03AK08 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
