Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Enjaymo 50 mg/mL solution for infusion.
| Pharmaceutical Form |
|---|
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Solution for infusion (infusion). Opalescent, colourless to slightly yellow solution essentially free of visible particles, with a pH of approximately 6.1 and osmolality of 268-312 mOsm/Kg. |
Each mL of solution for infusion contains 50 mg of sutimlimab*.
One vial contains 1 100 mg of sutimlimab in 22 mL.
* Sutimlimab is an immunoglobulin G4 (IgG4) monoclonal antibody (mAb) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient with known effect: Each mL of solution for infusion contains 3.5 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sutimlimab |
Sutimlimab is an IgG, subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1s), a serine protease that cleaves C4. The activities of the lectin and alternative complement pathways are not inhibited by sutimlimab. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of red blood cells, resulting in inhibition of haemolysis in patients with CAD. |
| List of Excipients |
|---|
|
Polysorbate 80 (E433) |
22 mL solution in vial (type I glass) with a stopper (butyl rubber), seal (aluminium) and a flip-off cap
Each pack contains 1 or 6 vials.
Not all pack sizes may be marketed.
Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/22/1687/001
EU/1/22/1687/002
Date of first authorisation: 15 November 2022
| Drug | Countries | |
|---|---|---|
| ENJAYMO | Austria, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, United States |
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