Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Galderma International, La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen.
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection Powder for solution for injection: lyophilised white powder. Solvent for solution for injection: A clear, colourless solution. |
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen: Each single-use pre-filled pen contains 30 mg of nemolizumab per 0.49 ml dose following reconstitution.
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 30 mg of nemolizumab per 0.49 ml dose following reconstitution.
Nemolizumab, a humanised monoclonal modified immunoglobulin G (IgG) antibody, is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nemolizumab |
Nemolizumab is a humanised IgG2 monoclonal antibody that inhibits interleukin-31 (IL-31) signalling by binding selectively to interleukin-31 receptor alpha (IL-31 RA). IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemolizumab inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines. |
| List of Excipients |
|---|
|
Powder for solution for injection: Sucrose Solvent: Water for injections |
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen:
Single-use dual-chamber borosilicate glass type 1 cartridge in an auto-injector, with a stainless steel staked needle.
Pack size: 1 pre-filled pen, multipack containing 2 (2 packs of 1) pre-filled pens, multipack containing 3 (3 packs of 1) pre-filled pens.
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled syringe:
Single-use dual-chamber pre-filled syringe in a borosilicate glass type 1, co-packaged with a 27G needle (stainless steel) with safety shield.
Pack size: 1 pre-filled syringe
Not all pack sizes may be marketed.
Galderma International, La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France
EU/1/24/1901/001
EU/1/24/1901/002
EU/1/24/1901/003
EU/1/24/1901/004
| Drug | Countries | |
|---|---|---|
| NEMLUVIO | United States |
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