Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hizentra   
Auth. number : EU/1/11/687
Active substance : 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, children and adolescents (0-18 years) in:
− Primary immunodeficiency syndromes with impaired antibody production.
− Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
− Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients.
− Hypogammaglobulinaemia in patients pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).

Immunomodulatory therapy in adults, children and adolescents (0-18 years):
- Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
Marketing Authorisation Holder: CSL Behring GmbH
Emil-von-Behring-Straße 76, 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 - Notification EMEA/H/C/2127/N/12
Updated with Decision(2012)3450 of 22/05/2012
2/03/2012 Centralised - Notification 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
1/08/2013 Centralised - Notification 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
Updated with Decision(2014)10105 of 16/12/2014
23/12/2013 Centralised - Yearly update (2013)9732 of 18/12/2013
31/03/2014 Centralised - Notification EMEA/H/C/2127/N/39
Updated with Decision(2014)10105 of 16/12/2014
23/10/2014 Centralised - Variation EMEA/H/C/2127/II/40
Updated with Decision(2014)10105 of 16/12/2014
18/12/2014 Centralised - Yearly update (2014)10105 of 16/12/2014
6/06/2015 Centralised - Notification EMEA/H/C/2127/N/50
Updated with Decision(2018)649 of 30/01/2018
22/02/2016 Centralised - Renewal EMEA/H/C/2127/R/54 (2016)1143 of 18/02/2016
21/10/2016 Centralised - Notification EMEA/H/C/2127/N/73
Updated with Decision(2018)649 of 30/01/2018
20/02/2017 Centralised - Variation EMEA/H/C/2127/IB/76
Updated with Decision(2018)649 of 30/01/2018
14/09/2017 Centralised - Variation EMEA/H/C/2127/II/74
Updated with Decision(2018)649 of 30/01/2018
1/02/2018 Centralised - Yearly update (2018)649 of 30/01/2018
7/03/2018 Centralised - 2-Monthly update EMEA/H/C/2127/II/87 (2018)1484 of 5/03/2018