Mirtazapin Genericon 45 mg filmom obložene tablete
| Name | Mirtazapin Genericon 45 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-484578222 |
| Active Substance | mirtazapin |
| Composition | jedna filmom obložena tableta sadrži 45 mg mirtazapina |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Emona Biopharma razvoj proizvodnja in prodaja d.o.o., Ljubljana, Slovenija
Genericon Pharma Gesellschaft m.b.H., Graz, Austrija |
| Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date | 14.10.2025 |
| MA Period of Validity | 14.10.2030 |
| Classification Number | UP/I-530-09/24-01/167 |
| Registration Number | 381-12-01/171-25-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N06AX11 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
