Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Ilumetri 100 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to slightly opalescent and colourless to slightly yellow. The solution pH is in the range of 5.7-6.3 and the osmolality is between 258 and 311 mOsm/kg. |
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Tildrakizumab is a humanised IgG1/k 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 | |
|---|---|---|
| Tildrakizumab |
Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin-23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines. |
| List of Excipients |
|---|
|
L-Histidine |
1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x 1⁄2" needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Pack size of 1 pre-filled syringe or 2 pre-filled syringes.
Not all pack sizes may be marketed.
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
EU/1/18/1323/001
EU/1/18/1323/002
Date of first authorisation: 17 september 2018
| Drug | Countries | |
|---|---|---|
| ILUMETRI | Austria, Estonia, Spain, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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