DARZALEX conc perf 400 mg/20ml flac 20 ml

7680660720048 CH-66072 L01FC01 07.16.1.

Active substances:

DARZALEX conc perf 400 mg/20ml flac 20 ml
DARZALEX conc perf 400 mg/20ml flac 20 ml
DARZALEX conc perf 400 mg/20ml flac 20 ml
1 / 3
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Details

Product number
6607204
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
daratumumabum 400 mg, histidinum, histidini hydrochloridum monohydricum, sorbitolum 1093.0 mg, methioninum, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 5 ml.

Articles (1)

Darzalex 400mg/20ml, 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
25/09/2026
Professional SmPC
Français
25/09/2026
Professional SmPC
Italien
25/09/2026

Detailed composition

Substance Quantity Type Category
daratumumabum
400.0 MG Substance Wirkstoff (Principe actif)
histidinum
- Substance HNIDK
histidini hydrochloridum monohydricum
- Substance HNIDK
sorbitolum
1093.0 MG Substance HBESI
methioninum
- Substance HNIDK
polysorbatum 20
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK

Reimbursement information

Public price
CHF 1681.85
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/06/2017

Authorization holder

Janssen-Cilag AG

6300 Zug

Authorization information

Swissmedic authorization number
66072
Drug name
Darzalex, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOPA
ATC Code
L01FC01
Authorization status
Z
Dispensation category
A
First authorization
06/12/2016
Authorization expiration date
31/12/9999
IT number
07.16.1.
Domain
Human medicine
Field of application
Multiples Myelom

Packaging details

Description (FR)
DARZALEX conc perf 400 mg/20ml flac 20 ml
Description (DE)
DARZALEX Inf Konz 400 mg/20ml Durchstf 20 ml
Market launch
13/11/2023
Narcotic (BTM)
No

Other packaging sizes

DARZALEX conc perf 100 mg/5ml flac 5 ml
1 DUR
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