| Name |
Deksametazon Zentiva 4 mg tablete |
| Marketing Authorisation Number |
HR-H-003645847 |
| Active Substance |
deksametazon |
| Composition |
svaka tableta sadrži 4 mg deksametazona |
| Pharmaceutical Form |
Tableta |
| Manufacturer |
S.C. Zentiva S.A., Bukurešt, Rumunjska |
| Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date |
16.06.2023 |
| MA Period of Validity |
16.06.2028 |
| Classification Number |
UP/I-530-09/21-01/256 |
| Registration Number |
381-12-01/154-23-08 |
| 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 |
H02AB02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |