TEPEZZA 500 mg / 500 mg / 1 flacon(s)

7680697950012 CH-69795 L04AG13 07.15.0.
TEPEZZA 500 mg / 500 mg / 1 flacon(s)
TEPEZZA 500 mg / 500 mg / 1 flacon(s)
TEPEZZA 500 mg / 500 mg / 1 flacon(s)
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Details

Product number
6979501
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
teprotumumabum 500 mg, histidinum, histidini hydrochloridum monohydricum, trehalosum dihydricum, polysorbatum 20, pro vitro.

Articles (1)

Tepezza 500 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
16/06/2025
Professional SmPC
Français
16/06/2025
Professional SmPC
Italien
16/06/2025

Detailed composition

Substance Quantity Type Category
(N/A)
500.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK

Authorization holder

Amgen Switzerland AG

6343 Risch

Authorization information

Swissmedic authorization number
69795
Drug name
Tepezza, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Galenic form
PULPI
ATC Code
L04AG13
Authorization status
Z
Dispensation category
A
First authorization
30/04/2025
Authorization expiration date
29/04/2030
IT number
07.15.0.
Domain
Human medicine
Field of application
Behandlung von Erwachsenen mit mittelschwerer bis schwerer aktiver TED (Thyroid Eye Disease)

Packaging details

Description (FR)
TEPEZZA 500 mg / 500 mg / 1 flacon(s)
Description (DE)
TEPEZZA 500 mg / 500 mg / 1 Durchstechflasche(n)
Market launch
13/02/2026
Narcotic (BTM)
No