Zutectra (human hepatitis B immunoglobulin)

Region: 🇪🇺 EU
Active substance: human hepatitis B immunoglobulin
Company: Biotest Pharma GmbH
Status: Authorised
Therapeutic area: Immunization, Passive; Hepatitis B; Liver Transplantation
EU approval: Mon 30 Nov 2009
Application: EMEA/H/C/001089
ATC: J06BB04
Official record: www.ema.europa.eu

Indication

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

🇪🇺 ImmunoGam Withdrawn · Cangene Europe Limited

Follow Zutectra

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

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.