Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: HyQvia   
Auth. number : EU/1/13/840
Active substance : 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, 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 (CLL), in whom prophylactic antibiotics have failed or are contra indicated.
• Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.
• Hypogammaglobulinaemia in patients pre and post allogeneic hematopoietic stem cell transplantation (HSCT).
Marketing Authorisation Holder: Baxalta 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
Updated with Decision(2014)10104 of 16/12/2014
18/12/2014 Centralised - Yearly update (2014)10104 of 16/12/2014
16/03/2015 Centralised - Notification EMEA/H/C/2491/N/11
Updated with Decision(2016)3304 of 26/05/2016
26/05/2015 Centralised - Variation EMEA/H/C/2491/IAin/15
Updated with Decision(2016)3304 of 26/05/2016
03/06/2015 Centralised - Variation EMEA/H/C/2491/IAin/16
Updated with Decision(2016)3304 of 26/05/2016
25/06/2015 Centralised - Variation EMEA/H/C/2491/II/13
Updated with Decision(2016)3304 of 26/05/2016
19/11/2015 Centralised - Variation EMEA/H/C/2491/WS/790
Updated with Decision(2016)3304 of 26/05/2016
02/02/2016 Centralised - Variation EMEA/H/C/2491/IB/24
Updated with Decision(2016)3304 of 26/05/2016
25/02/2016 Centralised - Variation EMEA/H/C/2491/II/22
Updated with Decision(2016)3304 of 26/05/2016
28/04/2016 Centralised - Variation EMEA/H/C/2491/IAIN/27G
Updated with Decision(2016)3304 of 26/05/2016
30/05/2016 Centralised - Yearly update (2016)3304 of 26/05/2016
06/06/2016 Centralised - 2-Monthly update EMEA/H/C/2491/II/21 (2016)3479 of 01/06/2016