AREXVY subst sèche c solv flac

7680693100015 CH-69310 J07BX05 08.08.
AREXVY subst sèche c solv flac
AREXVY subst sèche c solv flac
AREXVY subst sèche c solv flac
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Details

Product number
6931001
CPT
-
Packaging group
1
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
1
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
30/07/2025
Professional SmPC
Français
30/07/2025
Professional SmPC
Italien
30/07/2025

Detailed composition

Substance Quantity Type Category
I
120.0 UG Substance Wirkstoff (Principe actif)
II
- Substance HNIDK
12C
120.0 UG Substance Wirkstoff (Principe actif)
12C
- Substance HNIDK
I
- Substance HNIDK
II
- Substance HNIDK
12C
- Substance HNIDK
II
- Substance HNIDK
I
- Substance HNIDK
I
- Substance HNIDK
II
- Substance HNIDK
12C
- Substance HNIDK
I
- Substance HNIDK
II
- Substance HNIDK
12C
- Substance HNIDK
12C
- Substance HNIDK
II
- Substance HNIDK
II
- Substance HNIDK
12C
- Substance HNIDK
II
- Substance HNIDK
12C
- Substance HNIDK
12C
- Substance HNIDK
12C
- Substance HNIDK
12C
- Substance HNIDK
12C
- Substance HNIDK
12C
1.78 MG Substance HBESI
12C
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 subst sèche c solv flac
Description (DE)
AREXVY Trockensub c Solv Durchstf
Market launch
02/05/2024
Narcotic (BTM)
No