Hizentra
·
- Prescription status not stated
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Human normal immunoglobulin (SCIg)
- Made by
- CSL Behring GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | CSL Behring GmbH |
|---|---|
| Active substance | Human normal immunoglobulin (SCIg) |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Classification | J06BA01 · Antibiotics, antivirals and antifungals taken into the body |
| Authorised on | 2011-04-14 |
| Last updated by the regulator | 2025-11-24 |
| EMA product number | EMEA/H/C/002127 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).