SAPROPTERIN DIPHARMA (Maple Healthcare Pty Ltd)
Product name
SAPROPTERIN DIPHARMA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
99 (255 working days)
Active ingredients
sapropterin dihydrochloride
Registration type
New generic medicine
Indication
TRADENAME is indicated for the treatment of hyperphenylalaninemia (HPA) in sapropterin responsive adult and paediatric patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION for definition of sapropterin responsiveness).