🇪🇺 Zutectra in European Union

EMA authorised Zutectra on 30 November 2009

Marketing authorisations

Application: EMEA/H/C/001089
Marketing authorisation holder: Biotest Pharma GmbH
Local brand name: Zutectra
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.
Status: approved

Application: EMEA/H/C/001055
Marketing authorisation holder: Cangene Europe Limited
Local brand name: ImmunoGam
Indication: Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of huma
Status: withdrawn

Is Zutectra approved in European Union?

Yes. EMA authorised it on 30 November 2009; EMA authorised it on 16 March 2010.

Who is the marketing authorisation holder for Zutectra in European Union?

Biotest Pharma GmbH holds the EU marketing authorisation.