Composition
- Active ingredients
- OMALIZUMAB-IGEC 150MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OMALIZUMAB-IGEC 300MG/2ML · InjectableBLA761399-003 · Prescription
- OMALIZUMAB-IGEC 75MG/0.5ML · InjectableBLA761399-001 · Prescription
- OMALIZUMAB-IGEC 150MG/ML · InjectableThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application BLA761399.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Omlyclo
- Active substance
- omalizumab-igec
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Celltrion Inc
- Status
- Prescription
- FDA approval
- 7 Mar 2025
- Application
- BLA761399-002