| Name |
Ketoprofen Dompé 50 mg obložene granule u vrećici |
| Marketing Authorisation Number |
HR-H-470519881 |
| Active Substance |
ketoprofenlizinat |
| Composition |
1 vrećica sadrži 50 mg ketoprofena (što odgovara 80 mg ketoprofenlizinata) |
| Pharmaceutical Form |
Obložene granule u vrećici |
| Manufacturer |
Dompé Farmaceutici S.p.A., L’Aquila, Italija |
| Marketing Authorisation Holder |
Dompé Farmaceutici S.p.A., Via San Martino 12, Milan, Italija |
| Marketing Authorisation Date |
13.12.2023 |
| MA Period of Validity |
13.12.2028 |
| Classification Number |
UP/I-530-09/22-01/118 |
| Registration Number |
381-12-01/70-23-10 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
allowed |
| ATC Code |
M01AE03 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
