Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hizentra   
Auth. number : EU/1/11/687
INN : human normal immunoglobulin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J06 - Immune sera and immunoglobulins
Pharmacological subgroup: J06B - Immunoglobulins
Chemical subgroup: J06BA - Immunoglobulins, normal human
Chemical substance: J06BA01 - Immunoglobulins, normal human, for extravascular administration
(See WHO ATC Index)
Indication: Replacement therapy in adults and children in primary immunodeficiency syndromes such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency
- severe combined immunodeficiency
- IgG subclass deficiencies with recurrent infections

Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Marketing Authorisation Holder: CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, 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
18/04/2011 Centralised - Authorisation EMEA/H/C/2127 (2011)2792 of 14/04/2011
26/10/2011 Centralised - Variation EMEA/H/C/2127/IB/8
Updated with Decision(2012)3450 of 22/05/2012
23/01/2012 Centralised - Variation EMEA/H/C/2127/N/12
Updated with Decision(2012)3450 of 22/05/2012
02/03/2012 Centralised - Variation EMEA/H/C/2127/N/13
Updated with Decision(2012)3450 of 22/05/2012
25/05/2012 Centralised - Variation (2012)3450 of 22/05/2012
17/01/2013 Centralised - Variation EMEA/H/C/2127/II/20/G
Updated with Decision(2013)9732 of 18/12/2013
17/06/2013 Centralised - Variation EMEA/H/C/2127/IAin/28
Updated with Decision(2013)9732 of 18/12/2013
01/08/2013 Centralised - Variation EMEA/H/C/2127/N/29
Updated with Decision(2013)9732 of 18/12/2013
14/08/2013 Centralised - Variation EMEA/H/C/2127/IA/33
Updated with Decision(2013)9732 of 18/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/2127/II/24
Updated with Decision(2013)9732 of 18/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/2127/II/27
23/12/2013 Centralised - Variation (2013)9732 of 18/12/2013
31/03/2014 Centralised - Variation EMEA/H/C/2127/N/39