Pharmaceuticals - Community Register

  

List of nationally authorised medicinal products for human use

Vivaglobin and associated names

Product name: Vivaglobin and associated names
Active substance: Human normal immunoglobulin
Indication: - Replacement of antibodies in adults and children suffering from congenital (primary) immunodeficiency syndromes suchas:
  • congenital absence of antibodies (agammaglobulinaemia) or antibody deficiency (hypogammaglobulinaemia);
  • common variable immunodeficiency;
  • severe combined immunodeficiency;
  • IgG subclass deficiencies with recurrent infections;
- Replacement of antibodies in:
  • cancer of bone marrow (myeloma);
  • malignant illness of white blood cells (chronic lymphatic leukaemia).
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
08/05/2012 Referral EMEA/H/A-36/1296 (2012)3143 of 07/05/2012