Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zutectra   
Auth. number : EU/1/09/600
Active substance : Human Hepatitis B Immunoglobulin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J06 - Immune sera and immunoglobulins
Pharmacological subgroup: J06B - Immunoglobulins
Chemical subgroup: J06BB - Specific immunoglobulins
Chemical substance: J06BB04 - hepatitis B immunoglobulin
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Biotest Pharma GmbH
Landsteinerstraße 5, 63303 Dreieich, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/12/2009 Centralised - Authorisation EMEA/H/C/1089 (2009)9772 of 30/11/2009
02/08/2010 Centralised - Variation EMEA/H/C/1089/IB/1
Updated with Decision(2011)975 of 11/02/2011
21/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1089/IA/3/G
03/01/2011 Centralised - Notification EMEA/H/C/1089/N/2
Updated with Decision(2011)975 of 11/02/2011
15/02/2011 Centralised - Variation (2011)975 of 11/02/2011
17/08/2011 Centralised - Variation EMEA/H/C/1089/IA/4/G
Updated with Decision(2011)8957 of 28/11/2011
13/10/2011 Centralised - Notification EMEA/H/C/1089/N/5
Updated with Decision(2011)8957 of 28/11/2011
30/11/2011 Centralised - Variation (2011)8957 of 28/11/2011
20/11/2012 Centralised - Notification EMEA/H/C/1089/N/7
Updated with Decision(2014)3952 of 06/06/2014
27/06/2013 Centralised - Variation EMEA/H/C/1089/II/8
Updated with Decision(2014)3952 of 06/06/2014
19/09/2013 Centralised - Notification EMEA/H/C/1089/N/12
Updated with Decision(2014)3952 of 06/06/2014
18/12/2013 Centralised - Variation EMEA/H/C/1089/IA/14/G
Updated with Decision(2014)3952 of 06/06/2014
11/06/2014 Centralised - Yearly update (2014)3952 of 06/06/2014
18/09/2014 Centralised - Renewal EMEA/H/C/1089/R/15 (2014)6737 of 16/09/2014
22/01/2015 Centralised - Notification EMEA/H/C/1089/N/20
Updated with Decision(2015)9627 of 16/12/2015
18/12/2015 Centralised - 2-Monthly update EMEA/H/C/1089/II/24 (2015)9627 of 16/12/2015
01/08/2016 Centralised - Notification EMEA/H/C/1089/N/29
17/05/2018 Centralised - Variation EMEA/H/C/1089/WS/1360