Amzelix 10 mg/20 mg filmom obložene tablete
| Name | Amzelix 10 mg/20 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-641574453 |
| Active Substance | donepezilklorid hidrat memantinklorid |
| Composition | jedna tableta sadrži 10 mg donepezilklorida u obliku donepezilklorid hidrata (što odogvara 9,14 mg donepezila) i 20 mg memantinklorida (što odgovara 16,62 mg memantina) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Laboratorios Alter S.A., Madrid, Španjolska |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 16.12.2022 |
| MA Period of Validity | 16.12.2027 |
| Classification Number | UP/I-530-09/21-01/64 |
| Registration Number | 381-12-01/70-22-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N06DA52 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
