Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: HyQvia   
Auth. number : EU/1/13/840
INN : 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: J06BA - Immunoglobulins, normal human
(See WHO ATC Index)
Indication: Replacement therapy in adults (> 18 years) in primary immunodeficiency syndromes such as:
• congenital agammaglobulinaemia and hypogammaglobulinaemia
• common variable immunodeficiency
• severe combined immunodeficiency
• IgG subclass deficiencies with recurrent infections.
Replacement therapy in adults (> 18 years) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Marketing Authorisation Holder: Baxter Innovations GmbH
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
22/05/2013 Centralised - Authorisation EMEA/H/C/2491 (2013)2994 of 16/05/2013
18/12/2013 Centralised - Variation EMEA/H/C/2491/IA/3