Leponex 100 mg tablete
Name | Leponex 100 mg tablete |
---|---|
Marketing Authorisation Number | HR-H-154629710 |
Active Substance | klozapin |
Composition | svaka tableta sadrži 100 mg klozapina |
Pharmaceutical Form | tableta |
Packaging [MA Number for Packaging] | 50 tableta u blisteru, u kutiji [HR-H-154629710-01] |
Manufacturer | Mylan Hungary Kft, Komárom, Mađarska McDermott Laboratories Limited, t/a Gerard Laboratories, Dublin 13, Irska Madaus GmbH, Troisdorf, Njemačka |
Marketing Authorisation Holder | Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska |
Marketing Authorisation Date | 02.09.2016 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/14-02/262 |
Registration Number | 381-12-01/70-16-16 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N05AH02 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |