FDG-RMC 185 MBq/ml, otopina za injekciju
Name | FDG-RMC 185 MBq/ml, otopina za injekciju |
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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 |