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SAI - Detailed view

SWAN-PSMA-1007 1 ml / 10 ml, Injektionslösung 15 mL

Drug

SWAN-PSMA-1007, Injektionslösung
PET-Diagnose von PSMA-positivem Prostatakrebs
17.01.9. – tumourdiagnostics

HAM – Human medicine
LSINJ – Solution for injection
R – radiopharmaceutic products
A – Dispensed once only on prescription by a physician or veterinarian (A)

Z – approved
6/11/2024
6/10/2029

Dosage strength

SWAN-PSMA-1007 1 ml / 10 ml, Injektionslösung
PET-Diagnose von PSMA-positivem Prostatakrebs
01
Z – approved

Package

No information made available
A/NR – Authorised / not referenced 

15 mL vial(s)

001
Z – approved

Declaration

Component

222 MBq (18F)-PSMA-1007
dinatrii phosphas
kalii dihydrogenophosphas
natrii chloridum
kalii chloridum
0.075 ml ethanolum
60 mg ethanolum
natrii ascorbas
aqua ad iniectabile
4.6 mg natrium

Authorisation holder

7601001398085
SWAN Isotopen AG
Anna-Seiler-Allee 24
3010 Bern (BE)

Date of revision of the text

11/11/2024

Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.