XOLAIR (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
XOLAIR
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
omalizumab
Registration type
EOI
Indication
Chronic rhinosinusitis with nasal polyps (CRSwNP)
XOLAIR (solution for injection, powder for injection with diluent) is now also indicated as add?on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).