| Name |
Paracetamol Fresenius 10 mg/ml otopina za infuziju |
| Marketing Authorisation Number |
HR-H-439581767 |
| Active Substance |
paracetamol |
| Composition |
1 ml otopine za infuziju sadrži 10 mg paracetamola |
| Pharmaceutical Form |
Otopina za infuziju |
| Manufacturer |
Fresenius Kabi Polska Sp. z o.o., Kutno, Poljska |
| Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date |
15.05.2026 |
| MA Period of Validity |
15.05.2031 |
| Classification Number |
UP/I-530-09/25-01/147 |
| Registration Number |
381-12-01/70-26-10 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N02BE01 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
