Leponex 12,5 mg raspadljive tablete za usta

Name	Leponex 12,5 mg raspadljive tablete za usta
Marketing Authorisation Number	HR-H-990391998
Active Substance	klozapin
Composition	jedna raspadljiva tableta za usta sadrži 12,5 mg klozapina
Pharmaceutical Form	Raspadljiva tableta za usta
Manufacturer	Mylan Hungary Kft, Komárom, Mađarska
Marketing Authorisation Holder	Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska
Marketing Authorisation Date	25.03.2025
MA Period of Validity	25.03.2030
Classification Number	UP/I-530-09/23-01/359
Registration Number	381-12-01/171-25-08
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	nije stavljeno u promet
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
50 tableta u blisteru, u kutiji	HR-H-990391998-01	nije stavljeno u promet	-
50 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-990391998-02	nije stavljeno u promet	-

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.