New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ustekinumab 130mg ((5.0 mg/ml));   - concentrate for infusion - 5 mg/ml - active: ustekinumab 130mg ((5.0 mg/ml))   excipient: edetic acid histidine histidine hydrochloride monohydrate methionine polysorbate 80 sucrose water for injection - crohn's disease: stelara is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf-alpha antagonist or have medical contraindications to such therapies. other dose forms of stelara are approved for other indications (plaque psoriasis, and psoriatic arthritis). this dose form is not approved for these other indications. this dose form is only to be used for the induction dose associated with the treatment of crohn's disease.

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

janssen-cilag pty ltd - ustekinumab, quantity: 135 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine - crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - 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.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - plaque psoriasis,adults - 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.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agents for dermatitis, excluding corticosteroids - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment.children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment.chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy.eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

noumed pharmaceuticals limited - hydrocortisone 1%{relative} (synthesis uses no animal materials);  ;   - topical cream - 1 % - active: hydrocortisone 1%{relative} (synthesis uses no animal materials)     excipient: cetomacrogol 1000 cetostearyl alcohol chlorocresol liquid paraffin purified water white soft paraffin

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.

Israel - English - Ministry of Health

organon pharma israel ltd., israel - betamethasone as dipropionate; clotrimazole; gentamicin (as sulfate) - cream - clotrimazole 10 mg/g; betamethasone as dipropionate 0.5 mg/g; gentamicin (as sulfate) 1 mg/g - corticosteroids, potent, other combinations - treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria (sensitive to gentamicin) and fungi (sensitive to clotrimazole) or when the possibility of such infections is suspected. the cream is suitable for the use of oozing eczema.

Israel - English - Ministry of Health

organon pharma israel ltd., israel - betamethasone as dipropionate; gentamicin (as sulfate) - cream - gentamicin (as sulfate) 1 mg/g; betamethasone as dipropionate 0.5 mg/g - corticosteroids, potent, combinations with antibiotics - for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses when complicated by secondary infections caused by organisms susceptible to gentamycin.