Medicinal Products

Amzelix 10 mg/10 mg filmom obložene tablete

Name Amzelix 10 mg/10 mg filmom obložene tablete
Marketing Authorisation Number HR-H-362759035
Active Substance donepezilklorid hidrat
memantinklorid
Composition jedna tableta sadrži 10 mg donepezilklorida u obliku donepezilklorid hidrata (što odogvara 9,14 mg donepezila) i 10 mg memantinklorida (što odgovara 8,31 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-530-09/21-01/63
Registration Number 381-12-01/70-22-14
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code N06DA52
Marketing status stavljeno u promet
Shortage status nema nestašice
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Public Assessment Report download
Summary of risk management plan download

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