HyQvia

RSS

human normal immunoglobulin

Authorised
This medicine is authorised for use in the European Union.

Overview

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 24/08/2018

Authorisation details

Product details
Name
HyQvia
Agency product number
EMEA/H/C/002491
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
J06BA
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Baxalta Innovations GmbH
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
16/05/2013
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

26/07/2018 HyQvia - EMEA/H/C/002491 - II/0040/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 (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).

Assessment history

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