SAI - Detailed view

STELARA Inf Konz 130 mg/26ml Durchstf

Drug

Name

Stelara, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Morbus Crohn, Ulcerative Colitis

ATC

L04AC05 - USTEKINUMAB

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

LSPA – Parenteral solution

Remedy code

BT – biological medicines

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

66135

Initial registration date

6/2/2017

Expiry date

12/31/9999

Dosage strength

Name

Stelara 130 mg, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Morbus Crohn, Ulcerative Colitis

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680661350015

Trade status*

In trade from / since 6/2/2017

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

130 mg ustekinumabum

Excipient

histidinum
histidini hydrochloridum monohydricum
saccharum
polysorbatum 80
dinatrii edetas
methioninum
aqua ad iniectabile
2.5 µg/ml natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

3360.25

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001000902

Address

Janssen-Cilag AG
Gubelstrasse 34
6300 Zug (ZG)

Date of revision of the text

4/29/2025

Information for prof.

Leaflet

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