HyQvia
human normal immunoglobulin
Table of contents
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.
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 |
J06BA01
|
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 |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
16/05/2013
|
Contact address |
Product information
03/09/2020 HyQvia - EMEA/H/C/002491 - II/0056
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.
- 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).