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 150 mg Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) | |
| XOLAIR 75 mg Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
Omalizumab is an active ingredient of these brands:
Australia (AU)Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Cyprus (CY)Ecuador (EC)Estonia (EE)Finland (FI)France (FR)Hong Kong (HK)Ireland (IE)Israel (IL)Italy (IT)Japan (JP)Lithuania (LT)Netherlands (NL)New Zealand (NZ)Poland (PL)Romania (RO)Singapore (SG)South Africa (ZA)Spain (ES)Tunisia (TN)Turkey (TR)United Kingdom (UK)United States (US)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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