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.

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.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 280 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.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 420 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.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 560 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.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastic agents - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

roche products (pty) ltd - infusion (parenteral) - see ingredients - each vial contains obinutuzumab 1 000,0 mg

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

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - 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.

European Union - English - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastic agents - brukinsa as monotherapy 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.brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy.brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

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

abbvie pty ltd - venetoclax, quantity: 10 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; copovidone; sodium stearylfumarate; polysorbate 80; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of: ? patients with relapsed or refractory cll with 17p deletion, or ? patients with relapsed or refractory cll for whom there are no other suitable treatment options.