Site notifications

Sub menu

 
 

VOXZOGO (BioMarin Pharmaceutical Australia Pty Ltd)

Product name
VOXZOGO
Sponsor
BioMarin Pharmaceutical Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
125 (255 working days)
Active ingredients
vosoritide
Registration type
EOI
Indication

Voxzogo is indicated for the treatment of achondroplasia in paediatric patients whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Registration process

Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.

Help us improve this page