UPLIZNA conc perf 100 mg/10ml 3 flac 10 ml

7680693220010 CH-69322 L04AA47 07.15.0.
UPLIZNA conc perf 100 mg/10ml 3 flac 10 ml
UPLIZNA conc perf 100 mg/10ml 3 flac 10 ml
UPLIZNA conc perf 100 mg/10ml 3 flac 10 ml
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Details

Product number
6932201
CPT
-
Packaging group
3
Unit
Durchstechflasche(n)
Composition
inebilizumabum 100 mg, histidinum, histidini hydrochloridum monohydricum, natrii chloridum, trehalosum dihydricum, polysorbatum 80, aqua ad iniectabile, ad solutionem pro 10 ml corresp., natrium 16.1 mg.

Articles (1)

Uplizna 100 mg/10ml, Konzentrat zur Herstellung einer Infusionslösung
Konzentrat
3
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
03/09/2024
Professional SmPC
Français
03/09/2024
Professional SmPC
Italien
03/09/2024

Detailed composition

Substance Quantity Type Category
(N/A)
100.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
16.1 MG Substance HBESI

Authorization holder

Amgen Switzerland AG

6343 Risch

Authorization information

Swissmedic authorization number
69322
Drug name
Uplizna, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOINF
ATC Code
L04AA47
Authorization status
Z
Dispensation category
A
First authorization
04/03/2024
Authorization expiration date
03/03/2029
IT number
07.15.0.
Domain
Human medicine
Field of application
Behandlung von erwachsenen Patienten mit Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD), die Anti-Aquaporin-4-Immunglobulin G(AQP4-IgG)-seropositiv sind

Packaging details

Description (FR)
UPLIZNA conc perf 100 mg/10ml 3 flac 10 ml
Description (DE)
UPLIZNA Inf Konz 100 mg/10ml 3 Durchstf 10 ml
Market launch
04/03/2024
Narcotic (BTM)
No