HyQvia

human normal immunoglobulin

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product HyQvia. The marketing authorisation holder for this medicinal product is Baxalta Innovations GmbH.

The CHMP adopted an extension to the existing indication as follows:1

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).
  • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.

*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold, removed text as strikethrough

Key facts

Name
HyQvia
Agency product number
EMEA/H/C/002491
International non-proprietary name (INN) or common name
  • human normal immunoglobulin
Active substance
  • Human normal immunoglobulin
Therapeutic area
Immunologic Deficiency Syndromes
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.

Date opinion adopted
23/07/2020
Company name
Baxalta Innovations GmbH
Status
Positive
Application type
Post-authorisation

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