XEOMIN, (Merz Australia Pty Ltd)
Product name
XEOMIN,
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
199 (255 working days)
Active ingredients
incobotulinumtoxinA
Registration type
EOI
Indication
Xeomin is indicated in adults for the treatment of:
- Cervical dystonia (spasmodic torticollis)
- Blepharospasm
- Spasticity of the upper limb
- Chronic sialorrhea due to neurological disorders
- Upper facial lines
- Glabellar frown lines
- Lateral periorbital lines (crow’s feet)
- Horizontal forehead lines
Xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:
- Chronic sialorrhea due to neurological/neurodevelopmental disorders
- Spasticity of the lower and/or upper limbs