| Name |
Tiotepa Fresenius Kabi 100 mg prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-769572882 |
| Active Substance |
tiotepa |
| Composition |
jedna bočica praška sadrži 100 mg tiotepe nakon rekonstitucije s 10 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml) |
| Pharmaceutical Form |
Prašak za koncentrat za otopinu za infuziju |
| Manufacturer |
Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka |
| Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date |
24.03.2023 |
| MA Period of Validity |
24.03.2028 |
| Classification Number |
UP/I-530-09/20-01/310 |
| Registration Number |
381-12-01/38-23-08 |
| 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 |
L01AC01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
