Hizentra (human normal immunoglobulin (SCIg))
- Region
- 🇪🇺 EU
- Active substance
- human normal immunoglobulin (SCIg)
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Immunologic Deficiency Syndromes
- CHMP opinion
- Thu 17 Feb 2011
- EU approval
- Thu 14 Apr 2011
- Application
- EMEA/H/C/002127
- 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 (see section 4.4). - 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 (0-18 years): - Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
Regulatory milestones
No milestones recorded in the last year.
Follow Hizentra
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.