| 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 |
