Klozapin Alpha-Medical 25 mg tablete

Name	Klozapin Alpha-Medical 25 mg tablete
Former Name	Clozapine Remedica 25 mg tablete
Marketing Authorisation Number	HR-H-383928355
Active Substance	klozapin
Composition	svaka tableta sadrži 25 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-530-09/17-02/851
Registration Number	381-12-01/38-19-08
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	N05AH02
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
50 tableta u blisteru, u kutiji	HR-H-383928355-01	stavljeno u promet	nema nestašice

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.