| Name |
Pelaria sirup |
| Marketing Authorisation Number |
HR-H-812505691 |
| Active Substance |
suhi ekstrakt pelargonijinog korijena (DER 4-25:1), ekstrakcijsko otapalo: etanol 11% m/m |
| Composition |
2,5 ml sirupa sadrži 20 mg ekstrakta (u obliku suhog ekstrakta) (DER 4-25:1) iz Pelargonium sidoides DC (ljekovita pelargonija) i/ili Pelargonium reniforme Curt., radix (pelargonija, korijen). Ekstrakcijsko otapalo: etanol 11 % m/m. Jedan ml sirupa sadrži 8 mg ekstrakta (u obliku suhog ekstrakta) |
| Pharmaceutical Form |
Sirup |
| Manufacturer |
Phytopharm Klęka SA, Nowe Miasto Nad Warta, Poljska |
| Marketing Authorisation Holder |
Alpen Pharma GmbH, Steinenfeld 3, Zell am Harmersbach, Njemačka |
| Marketing Authorisation Date |
24.10.2025 |
| MA Period of Validity |
24.10.2030 |
| Classification Number |
UP/I-530-09/24-01/180 |
| Registration Number |
381-12-01/70-25-11 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
allowed |
| ATC Code |
R05X |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
