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🇪🇺EU · EMAAuthorisedATC: J06BA02

Deqsiga(human normal immunoglobulin)

Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Marketing Authorisation Holder: Takeda Manufacturing Austria AG

EMA Authorisation: 02/05/2025

INN: human normal immunoglobulin

Indication

Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) 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 vaccinesImmunomodulation in adults, children and adolescents (0 to 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome. - Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2). - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). - Multifocal Motor Neuropathy (MMN).

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.