Trabektedin Teva 1 mg prašak za koncentrat za otopinu za infuziju
Name | Trabektedin Teva 1 mg prašak za koncentrat za otopinu za infuziju |
---|---|
Marketing Authorisation Number | HR-H-602822922 |
Active Substance | trabektedin |
Composition | jedna bočica praška sadrži 1 mg trabektedina jedan ml rekonstituirane otopine sadrži 0,05 mg trabektedina |
Pharmaceutical Form | Prašak za koncentrat za otopinu za infuziju |
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 | 17.02.2022 |
MA Period of Validity | 17.02.2027 |
Classification Number | UP/I-530-09/20-01/265 |
Registration Number | 381-12-01/70-22-02 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01CX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |