Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
TEPEZZA 500 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white lyophilised powder. |
Each vial contains 500 mg of teprotumumab. Teprotumumab is a fully human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
The reconstituted solution contains 47.6 mg/mL (500 mg/10.5 mL) of teprotumumab.
Excipient with known effect:
This medicinal product contains 1.05 mg of polysorbate 20 in each 10.5 mL reconstituted volume.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Teprotumumab mechanism of action in patients with thyroid eye disease has not been fully characterised. Teprotumumab binds to IGF-1R and blocks its activation and signalling. |
| List of Excipients |
|---|
|
Histidine |
20 mL type I clear glass vial, with a grey stopper (flurotec coated chlorobutyl) and an aluminium seal with a polypropylene matte red flip-off cap.
Each carton contains one vial.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/25/1941/001
| Drug | Countries | |
|---|---|---|
| TEPEZZA | Estonia, Lithuania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.