Sindaxel 6 mg/ml koncentrat za otopinu za infuziju
| Name | Sindaxel 6 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-901822377 |
| Active Substance | paklitaksel |
| Composition | 1 ml koncentrata za otopinu za infuziju sadrži 6 mg paklitaksela |
| Pharmaceutical Form | koncentrat za otopinu za infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Actavis Italy S.p.A., Nerviano (MI), Italija |
| Marketing Authorisation Holder | Actavis Group PTC ehf., Dalshraun 1, Hafnarfjoerdur, Island |
| Marketing Authorisation Date | 22.09.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/403 |
| Registration Number | 381-12-01/30-17-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01CD01 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
