Kabazitaksel Teva 10 mg/ml koncentrat za otopinu za infuziju
| Name | Kabazitaksel Teva 10 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-884840734 |
| Active Substance | kabazitaksel |
| Composition | jedan ml koncentrata za otopinu za infuziju sadrži 10 mg kabazitaksela (u obliku kabazitaksel 2-propanola) jedna bočica sa 6 ml koncentrata za otopinu za infuziju sadrži 60 mg kabazitaksela (u obliku kabazitaksel 2-propanola) |
| Pharmaceutical Form | Koncentrat za otopinu za infuziju |
| Packaging [MA Number for Packaging] | 1 bočica s 6 ml koncentrata, u kutiji [HR-H-884840734-01] |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 07.07.2022 |
| MA Period of Validity | 07.07.2027 |
| Classification Number | UP/I-530-09/21-01/115 |
| Registration Number | 381-12-01/14-22-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01CD04 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
