Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland
Taltz 80 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
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Solution for injection. The solution is clear and colourless to slightly yellow, with a pH not less than 5.2 and not more than 6.2, and an osmolarity not less than 235mOsm/kg and not more than 360 mOsm/kg. |
Each pre-filled pen contains 80 mg ixekizumab in 1 mL.
Ixekizumab is produced in CHO cells by recombinant DNA technology.
Excipient with known effect: One mL of solution contains 0.30 mg polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (<3 pM) and specificity to interleukin 17A (both IL-17A and IL-17A/F). Elevated concentrations of IL-17A have been implicated in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation, as well as in the pathogenesis of psoriatic arthritis and axial spondyloarthritis by driving inflammation leading to erosive bone damage and pathological new bone formation. Neutralisation of IL-17A by ixekizumab inhibits these actions. |
| List of Excipients |
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Sucrose |
1 mL solution in a type I clear glass syringe.
The syringe is encased in a disposable, single-dose pen.
Packs of 1, 2, or 3 pre-filled pens.
Not all pack sizes may be marketed.
Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland
EU/1/15/1085/001
EU/1/15/1085/002
EU/1/15/1085/003
Date of first authorisation: 25 April 2016
Date of latest renewal: 17 December 2020
| Drug | Countries | |
|---|---|---|
| TALTZ | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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