Aforbe 100/6 mikrograma po potisku, stlačeni inhalat, otopina
Name | Aforbe 100/6 mikrograma po potisku, stlačeni inhalat, otopina |
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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 | Hormosan Pharma GmbH, Frankfurt Am Main, Hesse, Njemačka Oy Medfiles Limited, Kuopio, Finska McDermott Laboratories Limited, t/a Mylan Dublin Respiratory, Dublin 13, Irska |
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 | nije stavljeno u promet |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |