Name |
Pulmozyme 2500 U/2,5 ml otopina za atomizator |
Marketing Authorisation Number |
HR-H-587894223 |
Active Substance |
dornaza alfa |
Composition |
jedna ampula sadrži 2500 jedinica (2,5 mg) dornaze alfa u 2,5 ml, što odgovara 1000 U/ml ili 1 mg/ml |
Pharmaceutical Form |
otopina za atomizator |
Manufacturer |
Roche Pharma AG, Grenzach-Wyhlen, Njemačka |
Marketing Authorisation Holder |
Roche d.o.o., Ulica grada Vukovara 269a, Zagreb, Hrvatska |
Marketing Authorisation Date |
30.04.2016 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/15-02/165 |
Registration Number |
381-12-01/70-16-09 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
R05CB13 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |