SIMPONI ser pré 50 mg/0.5ml 0.5 ml

7680612630012 CH-61263 L04AB06 07.15.0.

Active substances:

SIMPONI ser pré 50 mg/0.5ml 0.5 ml
SIMPONI ser pré 50 mg/0.5ml 0.5 ml
SIMPONI ser pré 50 mg/0.5ml 0.5 ml
1 / 3
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Details

Product number
6126301
CPT
-
Packaging group
1
Unit
Spritze(n)
Composition
golimumabum 50 mg, sorbitolum 20.5 mg, polysorbatum 80, histidinum, histidini hydrochloridum monohydricum, aqua ad iniectabile q.s. ad solutionem pro 0.5 ml.

Articles (1)

Simponi 50 mg, Injektionslösung in einer Fertigspritze
Injektionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
04/10/2024
Patient information leaflet
Français
04/10/2024
Patient information leaflet
Italien
04/10/2024
Professional SmPC
Allemand
04/10/2024
Professional SmPC
Français
04/10/2024
Professional SmPC
Italien
04/10/2024

Detailed composition

Substance Quantity Type Category
golimumabum
50.0 MG Substance Wirkstoff (Principe actif)
sorbitolum
20.5 MG Substance HBESI
polysorbatum 80
- Substance HNIDK
histidinum
- Substance HNIDK
histidini hydrochloridum monohydricum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK

Reimbursement information

Public price
CHF 932.85
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/12/2010

Authorization holder

Janssen-Cilag AG

6300 Zug

Authorization information

Swissmedic authorization number
61263
Drug name
Simponi, Injektionslösung in einer Fertigspritze
Galenic form
INLFS
ATC Code
L04AB06
Authorization status
Z
Dispensation category
B
First authorization
29/09/2010
Authorization expiration date
31/12/9999
IT number
07.15.0.
Domain
Human medicine
Field of application
Rheumatoide Arthritis, Psoriasis Arthritis, axiale Spondyloarthritis inkl. ankylosierende Spondylitis und nicht-radiographische axiale Spondyloarthritis, Colitis ulcerosa

Packaging details

Description (FR)
SIMPONI ser pré 50 mg/0.5ml 0.5 ml
Description (DE)
SIMPONI Fertspr 50 mg/0.5ml 0.5 ml
Market launch
29/09/2010
Narcotic (BTM)
No

Other packaging sizes

SIMPONI ser pré 100 mg/1ml 1 ml
1 SPRI
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