SAI - Detailed view

TEPEZZA 500 mg / 500 mg / 1 Durchstechflasche(n)

Drug

Name

Tepezza, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Field of application

Behandlung von Erwachsenen mit mittelschwerer bis schwerer aktiver TED (Thyroid Eye Disease)

ATC

L04AG13 - TEPROTUMUMAB

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

PULPI – powder for concentrate for solution for infusion

Remedy code

BT – biological medicines

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

69795

Initial registration date

4/30/2025

Expiry date

4/29/2030

Dosage strength

Name

Tepezza 500 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Field of application

Behandlung von Erwachsenen mit mittelschwerer bis schwerer aktiver TED (Thyroid Eye Disease)

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680697950012

Trade status*

In trade from / since 2/13/2026

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

500 mg teprotumumabum

Excipient

histidinum
histidini hydrochloridum monohydricum
trehalosum dihydricum
polysorbatum 20

Authorisation holder

GLN**

7601001369276

Address

Amgen Switzerland AG
6343 Risch (ZG)

Date of revision of the text

9/13/2025

Information for prof.

Leaflet

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