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IMBRUVICA (Janssen-Cilag Pty Ltd)
Product name
IMBRUVICA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
158 working days (255)
Active ingredients
ibrutinib
Registration type
EOI
Indication
IMBRUVICA (tablet) as a single agent or in combination with rituximab or 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.