| Name |
Pantoprazol Kalceks 40 mg prašak za otopinu za injekciju |
| Marketing Authorisation Number |
HR-H-381408276 |
| Active Substance |
pantoprazolnatrij seskvihidrat |
| Composition |
jedna bočica sadrži 40 mg pantoprazola (u obliku natrij seskvihidrata) |
| Pharmaceutical Form |
prašak za otopinu za injekciju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 53, Riga, Latvija |
| Marketing Authorisation Date |
16.05.2023 |
| MA Period of Validity |
16.05.2028 |
| Classification Number |
UP/I-530-09/21-01/303 |
| Registration Number |
381-12-01/70-23-09 |
| 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 |
A02BC02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
