AREXVY susp inj 120 µg 10 pce

7680693100039 CH-69310 J07BX05 08.08.

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Details

Product number
6931001
CPT
-
Packaging group
10
Unit
Durchstechflasche(n)
Composition
I): proteinum prae-fusionatum F viri sincitialis respiratorii 120 µg, trehalosum dihydricum, polysorbatum 80, kalii dihydrogenophosphas, dikalii phosphas anhydricus, pro vitro. II): Adeps A 3-O-desacyl-4’-monophosphorylatus, Quillajae saponariae Molina saponinum purificatum, 1,2-dioleoyl-sn-glycero-3-phosphocholinum, cholesterolum, dinatrii phosphas, kalii dihydrogenophosphas, natrii chloridum, aqua ad iniectabile q.s. ad suspensionem pro 0.5 ml. I) et II) corresp.: proteinum prae-fusionatum F viri sincitialis respiratorii 120 µg, trehalosum dihydricum, polysorbatum 80, kalii dihydrogenophosphas, dikalii phosphas anhydricus, Adeps A 3-O-desacyl-4’-monophosphorylatus, Quillajae saponariae Molina saponinum purificatum, 1,2-dioleoyl-sn-glycero-3-phosphocholinum, cholesterolum, natrii chloridum, dinatrii phosphas, aqua ad iniectabile q.s. ad suspensionem pro 0.5 ml corresp. natrium 1.78 mg, kalium 0.35 mg.

Articles (1)

AREXVY, Pulver und Suspension zur Herstellung einer Injektionssuspension
Pulver
10
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
28/04/2026
Professional SmPC
Français
28/04/2026
Professional SmPC
Italien
28/04/2026

Detailed composition

Substance Quantity Type Category
proteinum prae-fusionatum F viri sincitialis respiratorii
120.0 UG Substance Wirkstoff (Principe actif)
adeps A 3-O-desacyl-4’-monophosphorylatus
- Substance HNIDK
proteinum prae-fusionatum F viri sincitialis respiratorii
120.0 UG Substance Wirkstoff (Principe actif)
trehalosum dihydricum
- Substance HNIDK
trehalosum dihydricum
- Substance HNIDK
Quillajae saponariae Molina saponinum purificatum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
1,2-dioleoyl-sn-glycero-3-phosphocholinum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
kalii dihydrogenophosphas
- Substance HNIDK
cholesterolum
- Substance HNIDK
kalii dihydrogenophosphas
- Substance HNIDK
dikalii phosphas anhydricus
- Substance HNIDK
dinatrii phosphas
- Substance HNIDK
dikalii phosphas anhydricus
- Substance HNIDK
adeps A 3-O-desacyl-4’-monophosphorylatus
- Substance HNIDK
kalii dihydrogenophosphas
- Substance HNIDK
natrii chloridum
- Substance HNIDK
Quillajae saponariae Molina saponinum purificatum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
1,2-dioleoyl-sn-glycero-3-phosphocholinum
- Substance HNIDK
cholesterolum
- Substance HNIDK
natrii chloridum
- Substance HNIDK
dinatrii phosphas
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
1.78 MG Substance HBESI
kalium
0.35 MG Substance HBESI

Authorization holder

GlaxoSmithKline AG

6340 Baar

Authorization information

Swissmedic authorization number
69310
Drug name
AREXVY, Pulver und Suspension zur Herstellung einer Injektionssuspension
Galenic form
PULSIN
ATC Code
J07BX05
Authorization status
Z
Dispensation category
B
First authorization
02/05/2024
Authorization expiration date
01/05/2029
IT number
08.08.
Domain
Human medicine
Field of application
Aktive Immunisierung zur Vorbeugung einer durch RSV verursachten Erkrankung der unteren Atemwege von Erwachsenen ≥60 Jahren sowie von Erwachsenen zwischen 50 und 59 Jahren mit einem erhöhten Risiko für eine RSV-Erkrankung

Packaging details

Description (FR)
AREXVY susp inj 120 µg 10 pce
Description (DE)
AREXVY Inj Susp 120 µg 10 Stk
Market launch
02/05/2024
Narcotic (BTM)
No

Other packaging sizes

AREXVY subst sèche c solv flac
1 DUR
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