Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Privigen   
Auth. number : EU/1/08/446
Active substance : Human normal immunoglobulin (IVIg)
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: J06BA02 - Immunoglobulins, normal human, for intravascular administration
(See WHO ATC Index)
Indication: Replacement therapy in adults, and children and adolescents (0-18 years) in:
  • Primary immunodeficiency (PID) syndromes with impaired antibody production.
  • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.
  • Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.
  • Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
  • Congenital AIDS with recurrent bacterial infections.

Immunomodulation in adults, and children and adolescents (0-18 years) in:
  • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
  • Guillain-Barré syndrome.
  • Kawasaki disease.

Chronic inflammatory demyelinating polyneuropathy
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
29/04/2008 Centralised - Authorisation EMEA/H/C/831 (2008)1757 of 25/04/2008
08/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IA/2
18/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/7
28/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/4
28/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/3
28/08/2008 Centralised - Notification EMEA/H/C/831/N/5
Updated with Decision(2009)3815 of 07/05/2009
25/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IA/9
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/6
30/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/10
11/05/2009 Centralised - Variation EMEA/H/C/831/II/11 (2009)3815 of 07/05/2009
18/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/18
25/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IA/22
30/06/2009 Centralised - Variation EMEA/H/C/831/IB/20
Updated with Decision(2009)6622 of 21/08/2009
30/06/2009 Centralised - Variation EMEA/H/C/831/IB/19
Updated with Decision(2009)6622 of 21/08/2009
09/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/21
24/07/2009 Centralised - Notification EMEA/H/C/831/N/26
Updated with Decision(2010)594 of 27/01/2010
31/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/14,15,16
05/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/25
05/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/24
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/25
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/24
25/08/2009 Centralised - Variation EMEA/H/C/831/II/13, 17 (2009)6622 of 21/08/2009
01/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/30
02/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/27
25/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/23
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/29
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/28
29/01/2010 Centralised - Variation EMEA/H/C/831/II/31 (2010)594 of 27/01/2010
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/33
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/32
05/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/34
07/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IA/37
16/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/38
26/04/2010 Centralised - Variation EMEA/H/C/831/IB/36
Updated with Decision(2010)6013 of 26/08/2010
11/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/39
24/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IA/44
31/08/2010 Centralised - Variation EMEA/H/C/831/II/40, 41 (2010)6013 of 26/08/2010
20/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IB/43
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/42
04/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/45
10/01/2011 Centralised - Notification EMEA/H/C/831/N/48
Updated with Decision(2012)1910 of 19/03/2012
01/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/II/46
01/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/831/IAin/49
10/03/2011 Centralised - Notification EMEA/H/C/831/N/50
Updated with Decision(2012)1910 of 19/03/2012
29/07/2011 Centralised - Notification EMEA/H/C/831/N/53
Updated with Decision(2012)1910 of 19/03/2012
01/12/2011 Centralised - Variation EMEA/H/C/831/IA/56
Updated with Decision(2012)1910 of 19/03/2012
21/03/2012 Centralised - Variation EMEA/H/C/831/II/58 (2012)1910 of 19/03/2012
15/03/2013 Centralised - Renewal EMEA/H/C/831/R/65 (2013)1642 of 13/03/2013
28/03/2013 Centralised - 2-Monthly update EMEA/H/C/831/II/63 (2013)1894 of 26/03/2013
25/04/2013 Centralised - Variation EMEA/H/C/831/II/69
Updated with Decision(2014)7934 of 22/10/2014
03/10/2013 Centralised - Variation EMEA/H/C/831/IAin/78
Updated with Decision(2014)7934 of 22/10/2014
23/10/2013 Centralised - Notification EMEA/H/C/831/N/77
Updated with Decision(2014)7934 of 22/10/2014
18/03/2014 Centralised - Notification EMEA/H/C/831/N/83
Updated with Decision(2014)7934 of 22/10/2014
24/10/2014 Centralised - Yearly update (2014)7934 of 22/10/2014