| Name |
Oksaliplatin Kalceks 5 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-434230309 |
| Active Substance |
oksaliplatin |
| Composition |
1 ml koncentrata za otopinu za infuziju sadrži 5 mg oksaliplatina |
| Pharmaceutical Form |
Koncentrat za otopinu za infuziju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
29.01.2024 |
| MA Period of Validity |
29.01.2029 |
| Classification Number |
UP/I-530-09/22-01/120 |
| Registration Number |
381-12-01/70-24-09 |
| 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 |
L01XA03 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
