MABTHERA conc perf 500 mg/50 ml flac 50 ml

7680543780251 CH-54378 L01FA01 07.16.1.

Active substances:

MABTHERA conc perf 500 mg/50 ml flac 50 ml
MABTHERA conc perf 500 mg/50 ml flac 50 ml
1 / 2
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Details

Product number
5437802
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
rituximabum 500 mg, natrii citras dihydricus, polysorbatum 80, natrii chloridum, acidum hydrochloridum aut natrii hydroxidum, aqua ad iniectabile q.s. ad solutionem pro 50 ml corresp. natrium 263.2 mg.

Articles (1)

MabThera 500 mg/50 ml, Konzentrat zur Herstellung einer Infusionslösung
Konzentrat
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
31/03/2026
Professional SmPC
Français
31/03/2026
Professional SmPC
Italien
31/03/2026

Detailed composition

Substance Quantity Type Category
rituximabum
500.0 MG Substance Wirkstoff (Principe actif)
natrii citras dihydricus
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
natrii chloridum
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
263.2 MG Substance HBESI

Reimbursement information

Public price
CHF 1267.65
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 15/03/1998

Authorization holder

Roche Pharma (Schweiz) AG

4058 Basel

Authorization information

Swissmedic authorization number
54378
Drug name
MabThera, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOPA
ATC Code
L01FA01
Authorization status
Z
Dispensation category
A
First authorization
27/11/1997
Authorization expiration date
31/12/9999
IT number
07.16.1.
Domain
Human medicine
Field of application
Non-Hodgkin-Lymphom, Rheumatoide Arthritis, ANCA-assoziierte Vasculitis

Packaging details

Description (FR)
MABTHERA conc perf 500 mg/50 ml flac 50 ml
Description (DE)
MABTHERA Inf Konz 500 mg/50 ml Durchstf 50 ml
Market launch
27/11/1997
Narcotic (BTM)
No

Other packaging sizes

MABTHERA conc perf 100 mg/10 ml 2 flac 10 ml
2 DUR
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