Ikatibant Alpha-Medical 30 mg otopina za injekciju u napunjenoj štrcaljki
| Name | Ikatibant Alpha-Medical 30 mg otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-345249326 |
| Active Substance | ikatibantacetat |
| Composition | svaka napunjena štrcaljka od 3 ml sadržava ikatibantacetat koji odgovara količini od 30 mg ikatibanta svaki ml otopine sadržava 10 mg ikatibanta |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Eurofins Proxy Laboratories B.V., CM Leiden, Nizozemska
Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 20.04.2022 |
| MA Period of Validity | 20.04.2027 |
| Classification Number | UP/I-530-09/20-01/173 |
| Registration Number | 381-12-01/70-22-14 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B06AC02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
