FDG-RMC 185 MBq/ml, otopina za injekciju
| Name | FDG-RMC 185 MBq/ml, otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-697103896 |
| Active Substance | fludeoksiglukoza (18 F) |
| Composition | 1 ml otopine za injekciju sadrži 185 MBq fludeoksiglukoze [18F] na dan i sat umjeravanja |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Ruđer Medikol Ciklotron d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Ruđer Medikol Ciklotron d.o.o., Bijenička 54, Zagreb, Hrvatska |
| Marketing Authorisation Date | 26.05.2022 |
| MA Period of Validity | 26.05.2027 |
| Classification Number | UP/I-530-09/21-01/09 |
| Registration Number | 381-12-01/70-22-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | V09IX04 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
