DUPIXENT (Sanofi-Aventis Australia Pty Ltd)
Product name
DUPIXENT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
213 (255 working days)
Active ingredients
dupilumab
Registration type
EOI
Indication
DUPIXENT (solution for injection) is now also indicated for:
Atopic Dermatitis - Children 6 to 11 years of age.
Dupixent is indicated for the treatment of severe atopic dermatitis in patients aged 6 to 11 years old who are candidates for chronic systemic therapy. DUPIXENT is not intended for episodic use.
Chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).