Gemgerta 100 mg filmom obložene tablete
| Name | Gemgerta 100 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-936501792 |
| Active Substance | brivaracetam |
| Composition | jedna filmom obložena tableta sadrži 100 mg brivaracetama |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | AdAlvo Limited, San Gwann, Malta
Misom Labs Limited, San Gwann, Malta |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 16.01.2025 |
| MA Period of Validity | 16.01.2030 |
| Classification Number | UP/I-530-09/24-01/11 |
| Registration Number | 381-12-01/171-25-08 |
| 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 | N03AX23 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
