European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatic neoplasms, castration-resistant - antineoplastic agents - treatment of adult patients with prostate cancer.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - hiv infections - antivirals for systemic use - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 hiv‑1 rna copies/ml. as with other antiretroviral medicinal products, genotypic resistance testing should guide the use of edurant.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - leukemia, myeloid - antineoplastic agents - treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (aml), according to the world health organization (who) classification, who are not candidates for standard induction chemotherapy.

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as the sulfate - soluble powder - imazalil present as the sulfate imidazole active 1000.0 g/kg - fungicide

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

janssen-cilag pty ltd - ibrutinib, quantity: 560 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; iron oxide red; polyvinyl alcohol; macrogol 3350 - 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: 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.