Druniler 80 mg filmom obložene tablete
| Name | Druniler 80 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-518150408 |
| Active Substance | febuksostat hemihidrat |
| Composition | jedna filmom obložena tableta sadrži 80 mg febuksostata (u obliku hemihidrata) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka Lek Pharmaceuticals d.d., Ljubljana, Slovenija Rontis Hellas Medical and Pharmaceutical Products S.A., Larissa, Grčka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 29.11.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/138 |
| Registration Number | 381-12-01/38-22-06 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | M04AA03 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
