Sinoxal 50 mg prašak za otopinu za infuziju Sinoxal 100 mg prašak za otopinu za infuziju
| Name | Sinoxal 50 mg prašak za otopinu za infuziju Sinoxal 100 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-640588353 |
| Active Substance | oksaliplatin |
| Composition | 1 ml rekonstituirane otopine za infuziju sadrži 5 mg oksaliplatina |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Actavis Italy S.p.A., Nerviano (Milano), Italija |
| Marketing Authorisation Holder | Actavis Group PTC ehf., Dalshraun 1, Hafnarfjoerdur, Island |
| Marketing Authorisation Date | 30.09.2015 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/401 |
| Registration Number | 381-12-01/70-15-11 |
| 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 | Not marketed |
| SmPC | download |
| PL | download |
