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IMBRUVICA (Janssen-Cilag Pty Ltd)
Product name
IMBRUVICA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
138 working days (255)
Active ingredients
ibrutinib
Registration type
EOI
Indication
IMBRUVICA (capsules) is indicated for the treatment of patients with MCL who have received at least one prior therapy.
IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenstrom's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with Waldenstrom's macroglubulinaemia (WM).
IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic leukemia (CLL/SLL). Can be used in patients with deletion 17p.
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 leukemia (CLL/SLL) who have received at least one prior therapy. Can be used in patients with deletion 17p.