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SAI - Detailed view

DARZALEX SC Inj Lös 1800 mg/15ml Durchstf 15 ml

Drug

DARZALEX SC, Injektionslösung
Multiples Myelom, Leichtketten-Amyloidose
07.16.1. – cytostatics

HAM – Human medicine
LSINJ – Solution for injection
BT – biological medicines
A – Dispensed once only on prescription by a physician or veterinarian (A)

Z – approved
8/13/2020
12/31/9999

Dosage strength

DARZALEX SC 1800 mg/15 ml, Injektionslösung
Multiples Myelom, Leichtketten-Amyloidose
01
Z – approved

Package

7680676890018
In trade from / since 8/13/2020
A/R – Authorised / referenced 

1 vial(s)

001
Z – approved

Declaration

Component

1800 mg daratumumabum
hyaluronidasum humanum ADNr
histidinum
histidini hydrochloridum monohydricum
735.1 mg sorbitolum
methioninum
polysorbatum 20
aqua ad iniectabile

Spezialitätenliste***

SL
-
-
5220.80
None
Yes
10%
No

Authorisation holder

7601001000902
Janssen-Cilag AG
Gubelstrasse 34
6300 Zug (ZG)

Date of revision of the text

4/29/2025

Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.