| Name |
Urapidil Kalceks 50 mg otopina za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-803841965 |
| Active Substance |
urapidil |
| Composition |
1 ml otopine sadrži 5 mg urapidila. Jedna ampula od 10 ml otopine sadrži 50 mg urapidila |
| Pharmaceutical Form |
Otopina za injekciju / infuziju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
06.10.2023 |
| MA Period of Validity |
06.10.2028 |
| Classification Number |
UP/I-530-09/23-01/180 |
| Registration Number |
381-12-01/154-23-02 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
