AirBuFo Forspiro 320/9 mikrograma po dozi, prašak inhalata, dozirani
| Name | AirBuFo Forspiro 320/9 mikrograma po dozi, prašak inhalata, dozirani |
|---|---|
| Marketing Authorisation Number | HR-H-623053682 |
| Active Substance | budezonid formoterolfumarat dihidrat |
| Composition | svaka isporučena doza (inhalacijska doza) sadrži 320 mikrograma budezonida i 9 mikrograma formoterolfumarata dihidrata |
| Pharmaceutical Form | prašak inhalata, dozirani |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Salutas Pharma GmbH, Barleben, Njemačka Aeropharm GmbH, Rudolstadt, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 27.02.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/108 |
| Registration Number | 381-12-01/171-23-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R03AK07 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |