| Name |
Astepro 1,5 mg/ml sprej za nos, otopina |
| Marketing Authorisation Number |
HR-H-867652930 |
| Active Substance |
azelastinklorid |
| Composition |
1 ml otopine sadrži 1,5 mg azelastinklorida |
| Pharmaceutical Form |
sprej za nos, otopina |
| Manufacturer |
Madaus GmbH, Troisdorf, Njemačka |
| Marketing Authorisation Holder |
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date |
03.03.2023 |
| MA Period of Validity |
03.03.2028 |
| Classification Number |
UP/I-530-09/21-01/258 |
| Registration Number |
381-12-01/70-23-08 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
ponovljivi recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
R01AC03 |
| Marketing status |
nije stavljeno u promet |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
