Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Tezspire 210 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringe (injection). Clear to opalescent, colourless to light yellow solution. |
Each pre-filled syringe contains 210 mg tezepelumab in 1.91 mL solution (110 mg/mL).
Tezepelumab is a human monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tezepelumab |
Tezepelumab is a monoclonal antibody (IgG2λ) directed against thymic stromal lymphopoietin (TSLP), preventing its interaction with the heterodimeric TSLP receptor. In asthma, both allergic and non-allergic triggers induce TSLP production. Blocking TSLP with tezepelumab reduces a broad spectrum of biomarkers and cytokines associated with airway inflammation; however, the mechanism of action of tezepelumab in asthma has not been definitively established. |
| List of Excipients |
|---|
|
Acetic acid |
1.91 mL solution in a siliconized Type I glass pre-filled syringe subassembly consisting of a 27-gauge ½-inch (12.7 mm) stainless steel special thin wall needle covered with a rigid needle cover and bromobutyl plunger-stopper. The pre-filled syringe subassembly is assembled with a needle guard and an extended finger flange.
Pack containing 1 pre-filled syringe.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/22/1677/001
| Drug | Countries | |
|---|---|---|
| TEZSPIRE | Austria, Canada, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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