human normal immunoglobulin

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for HyQvia. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use HyQvia.

For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 30/03/2023

Authorisation details

Product details
Agency product number
Active substance
Human normal immunoglobulin
International non-proprietary name (INN) or common name
human normal immunoglobulin
Therapeutic area (MeSH)
Immunologic Deficiency Syndromes
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Baxalta Innovations GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Industriestrasse 67
A-1221 Vienna

Product information

27/10/2022 HyQvia - EMEA/H/C/002491 - II/0078

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Select ‘available languages’ to access the language you need.


Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Replacement therapy in adults, children and adolescents (0-18 years) in:

  • Primary immunodeficiency syndromes with impaired antibody production.
  • 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).

Assessment history

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