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🇪🇺EU · EMAAuthorisedATC: J06BA01

HyQvia(human normal immunoglobulin)

Immunologic Deficiency Syndromes;Polyradiculoneuropathy;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Marketing Authorisation Holder: Baxalta Innovations GmbH

EMA Authorisation: 16/05/2013

INN: human normal immunoglobulin

Indication

Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production. 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. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.