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 |
bez recepta |
Distribution |
u ljekarni |
Advertising to general public |
dopušteno |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |