SOGROYA (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
SOGROYA
Date registered
Evaluation commenced
Decision date
Approval time
200 (255 working days
Active ingredients
somapacitan
Registration type
EOI
Indication
The approved new indication is:
the replacement of endogenous growth hormone (GH) in paediatric patients aged 2 years and above with growth failure due to growth hormone deficiency (GHD).