Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Eisai GmbH, Edmund-Rumpler-Straße 360549 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
LEQEMBI 100 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow solution. The solution has a pH of approximately 5.0 and an osmolality of 350-430 mOsm/kg. |
Each mL of concentrate contains 100 mg of lecanemab.
One vial of 5 mL contains 500 mg of lecanemab (500 mg/5 mL).
One vial of 2 mL contains 200 mg of lecanemab (200 mg/2 mL).
Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody (mAb) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect:
One 2 mL vial contains 1.0 mg polysorbate 80 (E433).
One 5 mL vial contains 2.5 mg polysorbate 80 (E433).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Lecanemab is an IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta and reduces amyloid beta plaques. |
| List of Excipients |
|---|
|
Histidine (for pH-adjustment) |
2 mL of concentrate containing 200 mg lecanemab in a 6 mL vial (Type I clear glass), with a stopper (chlorobutyl) and a seal (aluminium) with a dark grey flip-off cap, in a pack size of 1.
5mL of concentrate containing 500 mg lecanemab in a 6 mL vial (Type I clear glass), with a stopper (chlorobutyl) and a seal (aluminium) with a white flip-off cap, in a pack size of 1.
Each carton contains one vial.
Not all pack sizes may be marketed.
Eisai GmbH, Edmund-Rumpler-Straße 360549 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
EU/1/24/1891/001
EU/1/24/1891/002
| Drug | Countries | |
|---|---|---|
| LEQEMBI | Lithuania, United States |
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