| 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 |
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 |
V09IX04 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
