SAI - Detailed view

ADTRALZA Inj Lös 150 mg/ml Fertspr 2 x 2 Stk

Drug

Name

Adtralza, Injektionslösung in einer Fertigspritze

Field of application

Behandlung von mittlerer bis schwerer atopischer Dermatitis von Erwachsenen, welche eine systemische Therapie benötigen

ATC

D11AH07 - TRALOKINUMAB

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

LSINJ – Solution for injection

Remedy code

BT – biological medicines

Dispensing categories

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

Authorisation status

Z – approved

Authorisation number

68229

Initial registration date

2/24/2022

Expiry date

2/23/2027

Dosage strength

Name

Adtralza 150mg/ml, Injektionslösung in einer Fertigspritze

Field of application

Behandlung von mittlerer bis schwerer atopischer Dermatitis von Erwachsenen, welche eine systemische Therapie benötigen

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680682290017

Trade status*

In trade from / since 5/27/2022

Status

A/R – Authorised / referenced

Package size

4 pre-filled syringe(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

150 mg tralokinumabum

Excipient

natrii acetas trihydricus
acidum aceticum glaciale
natrii chloridum
polysorbatum 80
aqua ad iniectabile
2.977 mg natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

1121.45

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001001022

Address

Leo Pharmaceutical Products Sarath Ltd.
8302 Kloten (ZH)

Date of revision of the text

7/4/2024

Information for prof.

Leaflet

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