Topotekan Alpha-Medical 4 mg prašak za koncentrat za otopinu za infuziju
| 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 | Venus Pharma GmbH, Werne, Njemačka
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 | L01XX17 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Summary of risk management plan | download |
