DEFERASIROX TLB, DEFERASIROX SIP, DEFERASIROX ANS (Southern XP IP Pty Ltd)
Product name
DEFERASIROX TLB, DEFERASIROX SIP, DEFERASIROX ANS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
167 (255 working days)
Active ingredients
deferasirox
Registration type
New generic medicine
Indication
DEFERASIROX TLB, DEFERASIROX SIP, DEFERASIROX ANS (film coated tablet) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older.
Deferasirox is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.
Deferasirox is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.