| Name |
Zonotte 7,5 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-894884019 |
| Active Substance |
zopiklon |
| Composition |
jedna filmom obložena tableta sadrži 7,5 mg zopiklona |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
PharmaS d.o.o., Popovača, Hrvatska |
| Marketing Authorisation Holder |
Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
| Marketing Authorisation Date |
02.06.2021 |
| MA Period of Validity |
02.06.2026 |
| Classification Number |
UP/I-530-09/20-01/73 |
| Registration Number |
381-12-01/30-21-13 |
| 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 |
N05CF01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|