| Name |
Ketoprofen Dompé 50 mg granule za oralnu otopinu u vrećici |
| Former Name |
Ketoprofen Pharmexon 50 mg granule za oralnu otopinu u vrećici |
| Marketing Authorisation Number |
HR-H-349184425 |
| Active Substance |
ketoprofenlizinat |
| Composition |
1 vrećica sadrži 50 mg ketoprofena što odgovara 80 mg ketoprofenlizinata |
| Pharmaceutical Form |
Granule za oralnu otopinu 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 |
12.02.2024 |
| MA Period of Validity |
10.06.2027 |
| Classification Number |
UP/I-530-09/21-01/72 |
| Registration Number |
381-12-01/70-24-14 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for non-renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
M01AE03 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
