Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Omvoh 300 mg concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear and colourless to slightly yellow solution with a pH of approximately 5.5 and an osmolarity of approximately 300 mOsm/L. |
Each vial contains 300 mg mirikizumab in 15 mL solution (20 mg/mL).
After dilution (see section 6.6), the final concentration is approximately 1.1 mg/mL to approximately 4.6 mg/mL for the treatment of ulcerative colitis and approximately 3.6 mg/mL to approximately 9 mg/mL for the treatment of Crohn’s disease.
Mirikizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect:
Each 15 mL vial contains approximately 60 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Mirikizumab is a humanised IgG4 monoclonal, anti-interleukin-23 (anti-IL-23) antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. In humans, selective blockade of IL-23 was shown to normalise production of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. |
| List of Excipients |
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Sodium citrate dihydrate (E331) |
15 mL concentrate in a type I clear glass vial with a chlorobutyl rubber stopper, an aluminium seal and polypropylene flip top.
Pack sizes of 1 vial and 3 vials.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/23/1736/001
EU/1/23/1736/011
Date of first authorisation: 26 May 2023
| Drug | Countries | |
|---|---|---|
| OMVOH | Austria, France, Croatia, Ireland, Italy, Japan, Lithuania, United States |
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