| Name |
Olfen 20 mg/g gel |
| Marketing Authorisation Number |
HR-H-841350554 |
| Active Substance |
diklofenakdietilamin |
| Composition |
1 g gela sadrži 23,2 mg diklofenakdietilamina što odgovara 20 mg diklofenaknatrija |
| Pharmaceutical Form |
gel |
| Manufacturer |
Merckle GmbH, Ulm, Njemačka |
| Marketing Authorisation Holder |
Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date |
02.12.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/110 |
| Registration Number |
381-12-01/171-24-04 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
allowed |
| ATC Code |
M02AA15 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |