| 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 |
26.02.2026 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/25-02/79 |
| Registration Number |
381-12-01/70-26-05 |
| 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 |
C02CA06 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
