Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE) and lowers free IgE levels. The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC Group | 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):
| Document | Type | Information Source | |
|---|---|---|---|
| XOLAIR 75 mg Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) | |
| XOLAIR 150 mg Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
Omalizumab is an active ingredient of these brands:
Australia (AU)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)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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