DEFERASIROX-TEVA, TE-DEFERASIROX (Teva Pharma Australia Pty Ltd)
Product name
DEFERASIROX-TEVA, TE-DEFERASIROX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
105 (175 working days)
Active ingredients
deferasirox
Registration type
New generic medicine
Indication
DEFERASIROX-TEVA, TE-DEFERASIROX (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-TEVA, TE-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-TEVA, TE-DEFERASIROX is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.