Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab binds to IgE and prevents binding of IgE to FcεRI (high-affinity IgE receptor) on basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the allergic cascade. Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcεRI receptors on basophils.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| R03DX05 | Omalizumab | R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DX Other systemic drugs for obstructive airway diseases |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| XOLAIR 150mg Solution for injection in pre-filled syringe | European Medicines Agency (EU) | MPI, EU: SmPC | |
| XOLAIR 75mg Solution for injection in pre-filled syringe | European Medicines Agency (EU) | MPI, EU: SmPC |
Omalizumab is an active ingredient of these brands:
United States (US)Australia (AU)Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Cyprus (CY)Ecuador (EC)Finland (FI)Hong Kong (HK)Ireland (IE)Israel (IL)Japan (JP)Netherlands (NL)New Zealand (NZ)Poland (PL)Romania (RO)Singapore (SG)South Africa (ZA)Spain (ES)Tunisia (TN)Turkey (TR)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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