Details

Product Name in the RMS: Radio-Flu 0,1-4 GBq/ml Injektionslösung

MR Number: DE/H/3517/001
Date of outcome: 09.07.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Bibliographic Chemical Substance Prescription Only
Active Substances	sodium fluoride 0,1 GBq
Form	Solution for injection
MA Holder in the RMS	Life Radiopharma Berlin GmbH Max-Planck-Strasse 4 12489 Berlin Germany
RMS	Germany
Date of last change	16.07.2021
ATC-Code	V09IX06 sodium fluoride (18F)

CMS Country	Domestic Product Name
Belgium
Lithuania	Natrio fluoridas (18F) Life Radiopharma 0,1-4 GBq/ml injekcinis tirpalas
Luxembourg
Netherlands
Poland	Radio-Flu
Sweden

Documents
FinalSPC:	DE_H_3517_001_FinalSPC_1of2.pdf (11.07.2014)
FinalSPC:	DE_H_3517_001_FinalSPC_2of2.pdf (11.07.2014)
FinalPL:	DE_H_3517_001_FinalPL.pdf (27.07.2018)
FinalLabelling:	DE_H_3517_001_FinalLabelling_1of2.pdf (11.07.2014)
FinalLabelling:	DE_H_3517_001_FinalLabelling_2of2.pdf (11.07.2014)
Finalised Product Information:	DE_H_3517_001_FinalPI_1of2.pdf (31.03.2021)
Finalised Product Information:	DE_H_3517_001_FinalPI_2of2.pdf (31.03.2021)