| Name |
Flenty 1 mg/g gel |
| Marketing Authorisation Number |
HR-H-403007218 |
| Active Substance |
dimetindenmaleat |
| Composition |
1 g gela sadrži 1 mg dimetindenmaleata |
| Pharmaceutical Form |
Gel |
| Manufacturer |
Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Holder |
Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Date |
12.07.2024 |
| MA Period of Validity |
12.07.2029 |
| Classification Number |
UP/I-530-09/23-01/134 |
| Registration Number |
381-12-01/70-24-09 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) and non-pharmacy outlets |
| Advertising to general public |
allowed |
| ATC Code |
D04AA13 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |