| Name |
Topotekan Alpha-Medical 4 mg prašak za koncentrat za otopinu za infuziju |
| Former Name |
Topotecan Alpha-medical 4 mg prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-918104024 |
| Active Substance |
topotekanklorid |
| Composition |
jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida)
1 ml rekonstituiranog koncentrata za otopinu sadrži 1 mg topotekana
|
| Pharmaceutical Form |
prašak za koncentrat za otopinu za infuziju |
| Manufacturer |
European Pharma Hub Kft., Gyal, Mađarska |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
21.11.2018 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/17-02/772 |
| Registration Number |
381-12-01/30-18-07 |
| 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 |
L01CE01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Summary of risk management plan |
download |
