| Name |
Lodixeon 50 mg suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki |
| Marketing Authorisation Number |
HR-H-849722721 |
| Active Substance |
paliperidonpalmitat |
| Composition |
Jedna napunjena štrcaljka sadrži 78 mg paliperidonpalmitata u 0,5 ml, što odgovara 50 mg paliperidona |
| Pharmaceutical Form |
Suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki |
| Manufacturer |
Viatris Sante , Lyon, Francuska |
| Marketing Authorisation Holder |
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date |
22.10.2025 |
| MA Period of Validity |
22.10.2030 |
| Classification Number |
UP/I-530-09/23-01/330 |
| Registration Number |
381-12-01/171-25-08 |
| 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 |
N05AX13 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
