New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - canagliflozin hemihydrate 306mg equivalent to canagliflozin 300 mg - film coated tablet - 300 mg - active: canagliflozin hemihydrate 306mg equivalent to canagliflozin 300 mg excipient: croscarmellose sodium hyprolose lactose magnesium stearate microcrystalline cellulose opadry white 85f18422 - invokana is indicated in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, to improve glycaemic control as: monotherapy: when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. add-on combination therapy: combination therapy with other anti-hyperglycaemic agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg;  ;   - tablet - 100 mg - active: bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg     excipient: colloidal silicon dioxide croscarmellose sodium hypromellose lactose monohydrate magnesium stearate maize starch microcrystalline cellulose polysorbate 20 - sirturo is indicated in adult (greater than or equal to 18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (tb) due to multi-drug resistant mycobacterium tuberculosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - abiraterone acetate 500mg - film coated tablet - 500 mg - active: abiraterone acetate 500mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry purple 85f90093 sodium laurilsulfate - zytiga is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (adt) for the treatment of high-risk metastatic hormone naive prostate cancer (mhnpc) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) zytiga is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mcprc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcprc) who have received prior chemotherapy containing a taxane.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 100 mg/5ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 400 mg/20ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

covax-kkm - rad26.cov2-s -

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen cilag ltd. - diclazuril - oral suspension - 2.5 mg/ml - bovine - coccidiostats

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

janssen-cilag pty ltd - imazalil present as the sulfate - fungicide - apple - post-harvest dip | citrus - post-harvest dip | pear - post-harvest dip | potato tuber - blue mould on citrus - p. italicum | blue mould on pome - p. expansum | fusarium dry rot | gangrene - phoma exigua | green mould | silver scurf

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

janssen-cilag pty ltd - imazalil - fungicide - citrus - post-harvest dip - blue mould on citrus - p. italicum | green mould

European Union - English - EMA (European Medicines Agency)

janssen pharmaceutica n.v. - mitratapide - antiobesity preparations, excl. diet products - dogs - as an aid in the management of overweight and obesity in adult dogs. to be used as part of an overall weight management programme which also includes appropriate dietary changes. introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.