Amzelix 10 mg/20 mg filmom obložene tablete
Name | Amzelix 10 mg/20 mg filmom obložene tablete |
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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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N06DA52 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |