ALEMBIC DEFERASIROX, CHEALAC, CHEALEMBIC, DEFERASIROX AGH, DEFERASIROX AGHL, DEFERASIROX APL, DEFERASIROX APPL, JADELEM (Alembic Pharmaceuticals Australia Pty Ltd)
Product name
ALEMBIC DEFERASIROX, CHEALAC, CHEALEMBIC, DEFERASIROX AGH, DEFERASIROX AGHL, DEFERASIROX APL, DEFERASIROX APPL, JADELEM
Date registered
Evaluation commenced
Decision date
Approval time
164 working days (255)
Active ingredients
deferasirox
Registration type
New generic medicine
Indication
ALEMBIC DEFERASIROX, CHEALAC, CHEALEMBIC, DEFERASIROX AGH, DEFERASIROX AGHL, DEFERASIROX APL, DEFERASIROX APPL, JADELEM (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.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine