Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Flebogamma DIF   
Auth. number : EU/1/07/404
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, children and adolescents (2-18 years) in:

- Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
- Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who failed to respond to pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogenic haematopoietic stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.

Immunomodulation in adults, children and adolescents (2-18 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.
Marketing Authorisation Holder: Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

  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
27/08/2007 Centralised - Authorisation EMEA/H/C/781 (2007)4052 of 23/08/2007
31/03/2008 Centralised - Variation EMEA/H/C/781/N/1
Updated with Decision(2009)6061 of 24/07/2009
30/07/2009 Centralised - Variation EMEA/H/C/781/II/5 (2009)6061 of 24/07/2009
16/04/2010 Centralised - Variation EMEA/H/C/781/IA/7
27/05/2010 Centralised - Variation EMEA/H/C/781/IA/8
13/08/2010 Centralised - Variation EMEA/H/C/781/II/9
03/09/2010 Centralised - Variation EMEA/H/C/781/IA/10
Updated with Decision(2010)9288 of 13/12/2010
17/11/2010 Centralised - Variation EMEA/H/C/781/IA/11
15/12/2010 Centralised - Variation EMEA/H/C/781/X/6 (2010)9288 of 13/12/2010
28/03/2011 Centralised - Variation EMEA/H/C/781/IA/12
15/03/2012 Centralised - Variation EMEA/H/C/781/IB/16
Updated with Decision(2012)6152 of 30/08/2012
04/09/2012 Centralised - Renewal EMEA/H/C/781/R/17 (2012)6152 of 30/08/2012
26/06/2013 Centralised - Variation EMEA/H/C/781/IAin/24
Updated with Decision(2014)4854 of 04/07/2014
06/06/2014 Centralised - Variation EMEA/H/C/781/N/34
Updated with Decision(2014)4854 of 04/07/2014
08/07/2014 Centralised - Variation (2014)4854 of 04/07/2014