Imraldi 40 mg/0.8 ml, Injektionslösung in einer Fertigspritze

7680674270010 CH-67427 L04AB04 07.15.0.

Active substances:

Imraldi 40 mg/0.8 ml, Injektionslösung in einer Fertigspritze
Imraldi 40 mg/0.8 ml, Injektionslösung in einer Fertigspritze
Imraldi 40 mg/0.8 ml, Injektionslösung in einer Fertigspritze
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Details

Product number
6742701
CPT
-
Packaging group
1
Unit
Fertigspritze(n)
Composition
adalimumabum 40 mg, natrii citras dihydricus, acidum citricum monohydricum, histidinum, histidini hydrochloridum monohydricum, sorbitolum 20 mg, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 0.8 ml corresp. natrium 0.375 mg.

Articles (1)

Imraldi 40 mg/0.8 ml, Injektionslösung in einer Fertigspritze
Injektionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
18/06/2025
Professional SmPC
Français
18/06/2025
Professional SmPC
Italien
18/06/2025

Detailed composition

Substance Quantity Type Category
adalimumabum
40.0 MG Substance Wirkstoff (Principe actif)
natrii citras dihydricus
- Substance HNIDK
acidum citricum monohydricum
- Substance HNIDK
histidinum
- Substance HNIDK
histidini hydrochloridum monohydricum
- Substance HNIDK
sorbitolum
20.0 MG Substance HBESI
polysorbatum 20
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
0.375 MG Substance HBESI

Authorization holder

Samsung Bioepis CH GmbH

6005 Luzern

Authorization information

Swissmedic authorization number
67427
Drug name
Imraldi, Injektionslösung in einer Fertigspritze
Galenic form
INLFS
ATC Code
L04AB04
Authorization status
Z
Dispensation category
B
First authorization
03/04/2020
Authorization expiration date
31/12/9999
IT number
07.15.0.
Domain
Human medicine
Field of application
Rheumatoide Arthritis, polyartikuläre juvenile idiopathische Arthritis, psoriatische Arthritis, ankylosierende Spondylitis (Morbus Bechterew), Morbus Crohn bei Erwachsenen, ulcerative Colitis, Plaque Psoriasis bei Erwachsenen, Hidradenitis suppurativa

Packaging details

Description (FR)
IMRALDI sol inj 40 mg/0.8ml ser préremp 0.8 ml
Description (DE)
IMRALDI Inj Lös 40 mg/0.8ml Fertigspr 0.8 ml
Market launch
03/04/2020
Market withdrawal
11/05/2026
Narcotic (BTM)
No

Other packaging sizes

IMRALDI sol inj 40 mg/0.8ml ser préremp 2 x 0.8 ml
2 FESP
View
IMRALDI sol inj 40 mg/0.8ml ser préremp 6 x 0.8 ml
6 FESP
View
IMRALDI sol inj 40 mg/0.4ml ser préremp 0.4 ml
1 FESP
View
IMRALDI sol inj 40 mg/0.4ml ser préremp 2 x 0.4 ml
2 FESP
View
IMRALDI sol inj 40 mg/0.4ml ser préremp 6 x 0.4 ml
6 FESP
View
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