New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) - suspension for injection - active: ad26.cov2.s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 8.92 log10 infectious units per dose) excipient: citric acid monohydrate ethanol hydrochloric acid hydroxypropyl-beta-cyclodextrin polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - covid-19 vaccine janssen has provisional consent for the indication below: active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ketoconazole 200mg - tablet - 200 mg - active: ketoconazole 200mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate maize starch microcrystalline cellulose povidone

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - haloperidol decanoate 50 mg/ml - injection (depot) - 50 mg/ml - active: haloperidol decanoate 50 mg/ml excipient: benzyl alcohol sesame oil - the maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - haloperidol decanoate 100 mg/ml - injection (depot) - 100 mg/ml - active: haloperidol decanoate 100 mg/ml - the maintenance therapy of psychoses, particularly for patients requiring prolonged parenteral neuroleptic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ustekinumab 45mg;   - solution for injection - 45 mg - active: ustekinumab 45mg   excipient: histidine as hydrochloride polysorbate 80 sucrose water for injection - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ustekinumab 90mg;   - solution for injection - 90 mg - active: ustekinumab 90mg   excipient: histidine as histidine hydrochloride polysorbate 80 sucrose water for injection - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during fp manufacture.) - powder for injection - 3.5 mg - active: bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during fp manufacture.) excipient: mannitol - velcade in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. velcade as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

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 - rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;   - film coated tablet - 25 mg - active: rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   excipient: croscarmellose sodium hypromellose lactose monohydrate   macrogol 3000 magnesium stearate microcrystalline cellulose polysorbate 20 povidone titanium dioxide triacetin - 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-na?ve patients with viral load nmt 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind controlled phase iii trials in treatment na?ve adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment na?ve adult patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - telaprevir 375mg;   - film coated tablet - 375 mg - active: telaprevir 375mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide croscarmellose sodium hypromellose acetate succinate iron oxide yellow macrogol 3350 microcrystalline cellulose polyvinyl alcohol purified talc sodium laurilsulfate sodium stearyl fumarate titanium dioxide - incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis c in adult patients with compensated liver disease (including cirrhosis): - who are treatment naive - who have previously been treated with interferon alfa (pegylated or nonpegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.