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IMBRUVICA (Janssen-Cilag Pty Ltd)
Product name
IMBRUVICA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
240 (255 working days)
Active ingredients
ibrutinib
Registration type
EOI
Indication
IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior therapy.