Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kiovig   
Auth. number : EU/1/05/329
INN : 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 syndromes with impaired antibody production (see section 4.4).
- 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 and 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.
- Multifocal Motor Neuropathy (MMN).
Marketing Authorisation Holder: Baxter AG
Industriestraße 67, A-1221 Wien, Österreich

  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
23/01/2006 Centralised - Authorisation EMEA/H/C/628 (2006)128 of 19/01/2006
03/05/2006 Centralised - Variation EMEA/H/C/628/IB/1
03/05/2006 Centralised - Variation EMEA/H/C/628/IA/2
03/08/2006 Centralised - Variation EMEA/H/C/628/II/3
15/08/2006 Centralised - Variation EMEA/H/C/628/N/5
Updated with Decision(2007)4022 of 21/08/2007
16/11/2006 Centralised - Variation EMEA/H/C/628/IB/7
21/11/2006 Centralised - Variation EMEA/H/C/628/II/6
29/01/2007 Centralised - Variation EMEA/H/C/628/II/8
01/03/2007 Centralised - Variation EMEA/H/C/628/IB/9
06/03/2007 Centralised - Variation EMEA/H/C/628/IB/10
23/08/2007 Centralised - Variation EMEA/H/C/628/II/13 (2007)4022 of 21/08/2007
26/09/2007 Centralised - Variation EMEA/H/C/628/II/11
31/10/2007 Centralised - Variation EMEA/H/C/628/IB/15
22/11/2007 Centralised - Variation EMEA/H/C/628/II/14
30/11/2007 Centralised - Variation EMEA/H/C/628/IB/16
30/03/2008 Centralised - Variation EMEA/H/C/628/I/18
05/06/2008 Centralised - Variation EMEA/H/C/628/II/19
28/07/2008 Centralised - Variation EMEA/H/C/628/II/17
23/03/2009 Centralised - Variation EMEA/H/C/628/II/21
14/08/2009 Centralised - Variation EMEA/H/C/628/IB/23
14/08/2009 Centralised - Variation EMEA/H/C/628/IB/22
14/08/2009 Centralised - Variation EMEA/H/C/628/IB/24
27/01/2010 Centralised - Variation EMEA/H/C/628/II/25 (2010)518 of 25/01/2010
02/02/2010 Centralised - Variation EMEA/H/C/628/IB/29
11/03/2010 Centralised - Variation EMEA/H/C/628/II/31
07/05/2010 Centralised - Variation EMEA/H/C/628/II/30 (2010)3078 of 05/05/2010
08/06/2010 Centralised - Variation EMEA/H/C/628/IA/35
05/07/2010 Centralised - Variation EMEA/H/C/628/II/26, 27, 28 (2010)4671 of 01/07/2010
10/08/2010 Centralised - Variation EMEA/H/C/628/II/33/G
10/08/2010 Centralised - Variation EMEA/H/C/628/II/34
14/09/2010 Corrigendum (2010)6328 corr of 10/09/2010
09/12/2010 Centralised - Renewal EMEA/H/C/628/R/36 (2010)8970 of 06/12/2010
29/07/2011 Centralised - Variation EMEA/H/C/628/II/37, 40 (2011)5580 of 27/07/2011
03/08/2012 Centralised - Variation EMEA/H/C/628/IB/46
Updated with Decision(2012)7992 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7992 of 31/10/2012
27/06/2013 Centralised - Variation EMEA/H/C/628/IAin/54
Updated with Decision(2014)3812 of 03/06/2014
24/10/2013 Centralised - Variation EMEA/H/C/628/II/50/G
Updated with Decision(2014)3812 of 03/06/2014
05/06/2014 Centralised - Variation (2014)3812 of 03/06/2014