Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Imaavy 185 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless to slightly brownish, clear to slightly opalescent, pH 6.0. |
Each mL of concentrate for solution for infusion contains 185 mg nipocalimab.
One vial of 1.62 mL contains 300 mg of nipocalimab.
One vial of 6.5 mL contains 1200 mg of nipocalimab.
Nipocalimab is a fully human immunoglobulin G1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient with known effect:
Each vial contains 0.97 mg (300 mg vial) or 3.9 mg (1200 mg vial) of polysorbate 80 which is equivalent to 0.60 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Nipocalimab is a human IgG1 monoclonal antibody specifically targeting the IgG Fc binding site of FcRn with high specificity and high affinity at both neutral (extracellular) and acidic pH (intracellular) resulting in the reduction of circulating IgG, including IgG autoantibodies, without affecting other immunoglobulins (IgA, IgE or IgM). |
| List of Excipients |
|---|
|
Arginine hydrochloride |
1.62 mL concentrate for solution for infusion in a single-use Type 1 glass vial with an elastomeric stopper with an aluminium seal with a flip-off cap containing 300 mg of nipocalimab. Pack size of 1 vial.
6.5 mL concentrate for solution for infusion in a single-use Type 1 glass vial with elastomeric stopper with an aluminium seal with a flip-off cap containing 1200 mg of nipocalimab. Pack size of 1 vial.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/25/1989/001
EU/1/25/1989/002
| Drug | Countries | |
|---|---|---|
| IMAAVY | Austria, Estonia, Lithuania, United States |
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