SWAN PSMA 1007 1 ml / 10 ml sol inj 222 MBq 15mL p

7680673700013 CH-67370 V09IX17 17.01.9.
SWAN PSMA 1007 1 ml / 10 ml sol inj 222 MBq 15mL p
SWAN PSMA 1007 1 ml / 10 ml sol inj 222 MBq 15mL p
SWAN PSMA 1007 1 ml / 10 ml sol inj 222 MBq 15mL p
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Details

GTIN
7680673700013
Pharmacode
-
Product number
6737001
CPT
-
Packaging group
15 mL
Unit
Durchstechflasche(n)
Composition
(18F)PSMA-1007 222 MBq, dinatrii phosphas, kalii dihydrogenophosphas, natrii chloridum, kalii chloridum, ethanolum 0.075 ml corresp. ethanolum 60 mg, natrii ascorbas, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium 4.6 mg.

Articles (1)

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

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
23/01/2025
Professional SmPC
Français
23/01/2025
Professional SmPC
Italien
23/01/2025

Detailed composition

Substance Quantity Type Category
(18F)-PSMA-1007
222.0 MBQ Substance Wirkstoff (Principe actif)
dinatrii phosphas
- Substance HNIDK
kalii dihydrogenophosphas
- Substance HNIDK
natrii chloridum
- Substance HNIDK
kalii chloridum
- Substance HNIDK
ethanolum
0.075 ML Substance HNIDK
ethanolum
60.0 MG Substance HBESI
natrii ascorbas
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
4.6 MG Substance HBESI

Authorization holder

SWAN Isotopen AG

3010 Bern

Authorization information

Swissmedic authorization number
67370
Drug name
SWAN-PSMA-1007, Injektionslösung
Galenic form
LSINJ
ATC Code
V09IX17
Authorization status
Z
Dispensation category
A
First authorization
11/06/2024
Authorization expiration date
10/06/2029
IT number
17.01.9.
Domain
Human medicine
Field of application
PET-Diagnose von PSMA-positivem Prostatakrebs

Packaging details

Description (FR)
SWAN PSMA 1007 1 ml / 10 ml sol inj 222 MBq 15mL p
Description (DE)
SWAN PSMA 1007 1 ml / 10 ml Inj Lös 222 MBq 15mL S
Market launch
11/06/2024
Narcotic (BTM)
No
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