| Name |
Cisplatin Pontus 1 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-523867276 |
| Active Substance |
cisplatin |
| Composition |
1 ml koncentrata za otopinu za infuziju sadrži 1 mg cisplatina |
| Pharmaceutical Form |
Koncentrat za otopinu za infuziju |
| Manufacturer |
European Pharma Hub Kft., Gyal, Mađarska |
| Marketing Authorisation Holder |
Pontus Pharma d.o.o., Ulica Kralja Zvonimira 62, Zagreb, Hrvatska |
| Marketing Authorisation Date |
07.01.2026 |
| MA Period of Validity |
07.01.2031 |
| Classification Number |
UP/I-530-09/24-01/25 |
| Registration Number |
381-12-01/171-26-08 |
| 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 |
L01XA01 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
