TALTZ Solution for injection Ref.[8982] Active ingredients: Ixekizumab

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

Taltz 80 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled syringe (injection).

The solution is clear and colourless to slightly yellow.

Qualitative and quantitative composition

Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.

Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ixekizumab

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. Neutralisation of IL-17A by ixekizumab inhibits these actions.
List of Excipients

Sodium citrate
Citric acid, anhydrous
Sodium chloride
Polysorbate 80
Water for injections

Pack sizes and marketing

1 ml solution in a type I clear glass syringe. Pack sizes of 1, 2, or 3 pre-filled syringes. Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/15/1085/004

EU/1/15/1085/005

EU/1/15/1085/006

Date of first authorisation: 25 April 2016

Drugs

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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