| 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 |
