Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: InflaRx GmbH, Winzerlaer Strasse 2, 07745 Jena, Germany
Gohibic 200 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless solution. |
Each vial contains 200 mg of vilobelimab in 20 mL.
Each mL of concentrate for solution for infusion contains 10 mg of vilobelimab. After dilution, each mL of solution contains 3.2 mg of vilobelimab.
Vilobelimab is a chimeric human/mouse monoclonal IgG4 antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient(s) with known effect: Each vial contains 74.2 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vilobelimab |
Vilobelimab is a chimeric human/mouse monoclonal IgG4 antibody that is a specific inhibitor of the soluble human complement component C5a. |
| List of Excipients |
|---|
|
Sodium chloride |
20 mL concentrate in a vial (type I clear glass) closed with a stopper (bromobutyl rubber) and sealed with a flip-off cap.
Pack size of 4 vials.
InflaRx GmbH, Winzerlaer Strasse 2, 07745 Jena, Germany
EU/1/24/1884/001
| Drug | Countries | |
|---|---|---|
| GOHIBIC | Lithuania, United States |
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