New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).

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

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

janssen pharmaceutica n.v. - imazalil present as imazalil sulphate; pyrimethanil - suspension concentrate - imazalil present as imazalil sulphate imidazole active 200.0 g/l; pyrimethanil pyrimidine active 200.0 g/l - fungicide - citrus | grapefruit | lemon | lime | mandarin | orange - blue and green moulds

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

janssen pharmaceutica n.v. - imazalil present as the sulfate - water soluble granules - imazalil present as the sulfate imidazole active 750.0 g/kg - fungicide - citrus - post-harvest dip | potato tuber - blue mould on citrus - p. italicum | fusarium dry rot | gangrene - phoma exigua | green mould | silver scurf

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

janssen-cilag s.p.a. - paliperidone - tablets prolonged-release - 6mg

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - methylphenidate hydrochloride; methylphenidate hydrochloride; methylphenidate hydrochloride - prolonged-release tablet - 18 milligram(s) - centrally acting sympathomimetics; methylphenidate

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - methylphenidate hydrochloride; methylphenidate hydrochloride; methylphenidate hydrochloride - prolonged-release tablet - 36 milligram(s) - centrally acting sympathomimetics; methylphenidate

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - fentanyl - transdermal patch - 100 micrograms/hour - phenylpiperidine derivatives; fentanyl