HyQvia (human normal immunoglobulin)
- Region
- 🇪🇺 EU
- Active substance
- human normal immunoglobulin
- Company
- Baxalta Innovations GmbH
- Status
- Authorised
- Therapeutic area
- Immunologic Deficiency Syndromes; Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- CHMP opinion
- Thu 21 Mar 2013
- EU approval
- Thu 16 May 2013
- Application
- EMEA/H/C/002491
- ATC
- J06BA01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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