Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 420 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica 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 waldenstr?m?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 macroglobulinaemia (wm).,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.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 280 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica 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 waldenstr?m?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 macroglobulinaemia (wm).,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.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - imbruvica 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 waldenstr?m?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 macroglobulinaemia (wm).,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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - ibrutinib - capsule - 140mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

cilag ag - ibrutinib - capsules - 140mg

European Union - English - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastic agents - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies. follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl).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 (cll) (see section 5.1).imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy.imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’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 wm.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - capsules - ibrutinib 140 mg - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - capsules - ibrutinib 140 mg - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 140 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.