Klozapin Alpha-Medical 100 mg tablete

Name	Klozapin Alpha-Medical 100 mg tablete
Former Name	Clozapine Remedica 100 mg tablete
Marketing Authorisation Number	HR-H-659500131
Active Substance	klozapin
Composition	svaka tableta sadrži 100 mg klozapina
Pharmaceutical Form	tableta
Manufacturer	Remedica Ltd., Limassol, Cipar
Marketing Authorisation Holder	Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date	29.10.2019
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/17-02/852
Registration Number	381-12-01/38-19-06
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	N05AH02
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
50 tableta u blisteru, u kutiji	HR-H-659500131-01	Marketed	No shortage

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o revidiranim preporukama za redovito praćenje krvne slike povezano s rizikom od agranulocitoze kod primjene lijekova koji sadrže klozapin	08.09.2025	Viatris Hrvatska d.o.o., Accord Healthcare Polska Sp. z o.o./PharmaS d.o.o., Alpha-Medical d.o.o., Makpharm d.o.o.