Gohibic (vilobelimab)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- vilobelimab
- Company
- InflaRx GmbH
- Status
- Authorised
- Therapeutic area
- Respiratory Distress Syndrome, Adult; COVID-19 virus infection
- CHMP opinion
- Thu 14 Nov 2024
- EU approval
- Mon 13 Jan 2025
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/006123
- ATC
- L04AJ10
- Official record
- www.ema.europa.eu
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)).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.