Leponex 200 mg tablete

Name	Leponex 200 mg tablete
Marketing Authorisation Number	HR-H-267582554
Active Substance	klozapin
Composition	jedna tableta sadrži 200 mg klozapina
Pharmaceutical Form	Tableta
Manufacturer	Madaus GmbH, Troisdorf, Njemačka
Marketing Authorisation Holder	Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska
Marketing Authorisation Date	12.11.2024
MA Period of Validity	12.11.2029
Classification Number	UP/I-530-09/23-01/159
Registration Number	381-12-01/171-24-09
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	Never marketed
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
20 tableta u blisteru, u kutiji	HR-H-267582554-01	Never marketed	-
30 tableta u blisteru, u kutiji	HR-H-267582554-02	Never marketed	-
40 tableta u blisteru, u kutiji	HR-H-267582554-03	Never marketed	-
50 tableta u blisteru, u kutiji	HR-H-267582554-04	Never marketed	-
100 tableta u blisteru, u kutiji	HR-H-267582554-05	Never marketed	-
20 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-267582554-06	Never marketed	-
30 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-267582554-07	Never marketed	-
40 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-267582554-08	Never marketed	-
50 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-267582554-09	Never marketed	-
100 tableta u blisteru s jediničnom dozom, u kutiji	HR-H-267582554-10	Never marketed	-

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.