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 |