MedPath
EMA Product

Gohibic

Product approved by European Medicines Agency (EU)

Basic Information

Gohibic

Regulatory Information

EMEA/H/C/006123

Authorised

January 13, 2025

November 14, 2024

February 3, 2025

Company Information

Germany

Winzerlaer Strasse 2 Ammerbach 07745 Jena

InflaRx GmbH

Drug Classification

Additional MonitoringExceptional Circumstances

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Gohibic is indicated for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).

Overview Summary

Gohibic is a medicine used to treat acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2 (the virus that causes COVID-19). ARDS is a condition in which swelling in the lungs causes inflammation and fluid to build up in the air sacs, causing severe difficulty breathing. Gohibic is used in adults who are being treated with corticosteroid (medicines to reduce inflammation) and mechanical ventilation (breathing assisted by a machine) with or without extracorporeal membrane oxygenation (ECMO, life support that can help a person whose lungs and heart aren't working properly). Gohibic contains the active substance vilobelimab.

© Copyright 2025. All Rights Reserved by MedPath