Raltegravir Viatris 600 mg filmom obložene tablete
| Name | Raltegravir Viatris 600 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-406064726 |
| Active Substance | raltegravirkalij |
| Composition | jedna filmom obložena tableta sadrži 600 mg raltegravira u obliku raltegravirkalija |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Mylan Hungary Kft, Komárom, Mađarska Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 13.05.2025 |
| MA Period of Validity | 13.05.2030 |
| Classification Number | UP/I-530-09/23-01/370 |
| Registration Number | 381-12-01/171-25-09 |
| 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 | J05AJ01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
