Acopair 18 mikrograma, prašak inhalata, tvrde kapsule
Name | Acopair 18 mikrograma, prašak inhalata, tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-567442892 |
Active Substance | tiotropijev bromid hidrat |
Composition | jedna kapsula sadrži 21,7 mikrograma tiotropij bromida što odgovara 18 mikrograma tiotropija. jedna isporučena doza (doza oslobođena iz nastavka za usta uređaja za inhalaciju NeumoHaler) sadrži 12 mikrograma tiotropija. |
Pharmaceutical Form | prašak inhalata, tvrda kapsula |
Packaging [MA Number for Packaging] | 30 kapsula u blisteru i inhalator, u kutiji [HR-H-567442892-01] 60 kapsula u blisteru i inhalator, u kutiji [HR-H-567442892-02] 90 kapsula u blisteru i inhalator, u kutiji [HR-H-567442892-03] |
Manufacturer | Ferrer Internacional S.A., Sant Cugat del Valles (Barcelona), Španjolska |
Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
Marketing Authorisation Date | 13.10.2021 |
MA Period of Validity | 23.10.2023 |
Classification Number | UP/I-530-09/17-01/94 |
Registration Number | 381-12-01/70-21-17 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | R03BB04 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |