| Name |
Trabektedin Teva 0,25 mg prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-420410111 |
| Active Substance |
trabektedin |
| Composition |
jedna bočica praška sadrži 0,25 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 |
| 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-530-09/20-01/264 |
| Registration Number |
381-12-01/70-22-04 |
| 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 |
