SEPHIENCE (PTC THERAPEUTICS AUSTRALIA PTY LIMITED)
Product name
SEPHIENCE
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
sepiapterin
Registration type
NCE/ NBE
Indication
SEPHIENCE is indicated for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.