FLIXABI subst seche 100 mg 3 pce

7680700870023 CH-70087 L04AB02 07.15.0.

Active substances:

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Details

Product number
7008701
CPT
-
Packaging group
3
Unit
Durchstechflasche(n)
Composition
infliximabum 100 mg, natrii dihydrogenophosphas monohydricus, dinatrii phosphas heptahydricus, saccharum, polysorbatum 80, pro vitro corresp. natrium 1.2554 mg.

Articles (1)

Flixabi 100 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
3
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
25/11/2025
Professional SmPC
Français
25/11/2025
Professional SmPC
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
Dispensation 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

Packaging 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 packaging sizes

FLIXABI subst seche 100 mg 1 pce
1 DUR
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