Name |
Plubir 18 mikrograma, prašak inhalata, tvrde kapsule |
Marketing Authorisation Number |
HR-H-761192159 |
Active Substance |
tiotropijev bromid |
Composition |
jedna kapsula sadrži 21,7 mikrograma tiotropijevog bromida što odgovara 18 mikrograma tiotropija jedna isporučena doza (doza oslobođena iz nastavka za usta uređaja za inhalaciju) sadrži 10 mikrograma tiotropija |
Pharmaceutical Form |
prašak inhalata, tvrda kapsula |
Manufacturer |
Helm AG, Hamburg, Njemačka |
Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
Marketing Authorisation Date |
26.02.2021 |
MA Period of Validity |
26.02.2026 |
Classification Number |
UP/I-530-09/19-01/238 |
Registration Number |
381-12-01/70-21-03 |
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
|