| Name |
Helex 2 mg tablete |
| Marketing Authorisation Number |
HR-H-662933581 |
| Active Substance |
alprazolam |
| Composition |
svaka tableta sadrži 2 mg alprazolama |
| Pharmaceutical Form |
tableta |
| Manufacturer |
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder |
Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date |
27.07.2023 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/22-02/179 |
| Registration Number |
381-12-01/286-23-05 |
| 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 |
N05BA12 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
