Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Teizeild 1 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear, colourless solution. |
One mL of concentrate for solution for infusion contains 1 mg of teplizumab.
Each vial contains 2 mg of teplizumab in 2 mL of concentrate (2 mg/2 mL).
Teplizumab is a monoclonal antibody (humanised IgG1 kappa) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect:
Each vial contains 7.45 mg of sodium and 0.10 mg of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood. |
| List of Excipients |
|---|
|
Dibasic sodium phosphate |
Teizeild is supplied in a 2 mL Type 1 borosilicate glass vial with a butyl rubber stopper and an aluminium seal with a coloured polypropylene flip-off cap.
Pack sizes of 1, 10 or 14 vials.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
EU/1/25/1998/001
EU/1/25/1998/002
EU/1/25/1998/003
| Drug | Countries | |
|---|---|---|
| TEIZEILD | Estonia, Lithuania |
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