Flixabi 100 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

7680700870023 CH-70087 Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

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Article details

Package size
3
Selling units
3
Measure
Durchstechflasche(n)
Galenic form
Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Galenic group
unbekannt

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Summary of Product Characteristics
Allemand
25/11/2025
Summary of Product Characteristics
Français
25/11/2025
Summary of Product Characteristics
Italien
25/11/2025

Detailed composition

Substance Quantity Type Category
infliximabum
100.0 MG Substance Wirkstoff (Principe actif)
natrii dihydrogenophosphas monohydricus
- Substance HNIDK
dinatrii phosphas heptahydricus
- Substance HNIDK
saccharum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
natrium
1.2554 MG Substance HBESI

Authorization holder

Samsung Bioepis CH GmbH

6005 Luzern

Authorization information

Swissmedic authorization number
70087
Drug name
Flixabi, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Galenic form
PULPI
ATC Code
L04AB02
Authorization status
Z
Dispensing category
A
First authorization
06/11/2025
Authorization expiration date
05/11/2030
IT Number
07.15.0.
Domain
Human medicine
Field of application
Rheumatoide Arthritis; Psoriatische Arthritis; Morbus Crohn; Morbus Bechterew; aktive ulcerative Colitis; Plaque-Psoriasis

Package details

Description (FR)
FLIXABI subst seche 100 mg 3 pce
Description (DE)
FLIXABI Trockensub 100 mg 3 Stk
Market launch
01/07/2027
Narcotic (BTM)
No

Other package sizes (1)

FLIXABI subst seche 100 mg 1 pce
1 DUR
GTIN: 7680700870016
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