Deqsiga (human normal immunoglobulin)
- Region
- 🇪🇺 EU
- Active substance
- human normal immunoglobulin
- Company
- Takeda Manufacturing Austria AG
- Status
- Authorised
- Therapeutic area
- Immunologic Deficiency Syndromes; Purpura, Thrombocytopenic, Idiopathic; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- CHMP opinion
- Thu 27 Feb 2025
- EU approval
- Fri 02 May 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006423
- ATC
- J06BA02
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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- 🇪🇺 Kiovig Authorised · Takeda Manufacturing Austria AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.