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 |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
A02BC02 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |