New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - galantamine hydrobromide 10.25mg equivalent to galantamine base 8 mg; galantamine hydrobromide 10.25mg equivalent to galantamine base 8 mg - modified release capsule - 8 mg - active: galantamine hydrobromide 10.25mg equivalent to galantamine base 8 mg excipient: diethyl phthalate ethylcellulose gelatin hypromellose opacode black s-1-27794 opadry clear oy-7240 sugar spheres titanium dioxide active: galantamine hydrobromide 10.25mg equivalent to galantamine base 8 mg excipient: diethyl phthalate ethylcellulose gelatin hypromellose opacode black s-1-277002 opadry clear oy-7240 sugar spheres - reminyl is indicated for the treatment of mild to moderately severe dementia of the alzheimer type.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 10 mg/ml - oral solution - 10 mg/ml - active: itraconazole 10 mg/ml excipient: caramel cherry flavour 654536 cherry flavour 654595 hydrochloric acid hydroxypropyl-beta-cyclodextrin propylene glycol purified water saccharin sodium sodium hydroxide sorbitol - sporanox oral solution is indicated for the: · treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. · prophylaxis of fungal infections in neutropenic patients.

Israel - English - Ministry of Health

j-c health care ltd - ketoconazole - shampoo - ketoconazole 20 mg / 1 g - ketoconazole - ketoconazole - topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including pityriasis versicolor.

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 - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - canagliflozin hemihydrate 102mg equivalent to canagliflozin 100 mg - film coated tablet - 100 mg - active: canagliflozin hemihydrate 102mg equivalent to canagliflozin 100 mg excipient: croscarmellose sodium hyprolose lactose magnesium stearate microcrystalline cellulose opadry ii yellow 85f92209 - 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 - 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.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen pharmaceutica n.v., belgium - haloperidol - solution for injection - 50 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen pharmaceutica n.v., belgium - econazole,triamcinolone acetonide - cream - 1,0.1 %

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone palmitate 156mg equivalent to 100 mg paliperidone base;   - suspension for injection - 100 mg - active: paliperidone palmitate 156mg equivalent to 100 mg paliperidone base   excipient: citric acid monohydrate dibasic sodium phosphate macrogol 4000 monobasic sodium phosphate monohydrate polysorbate 20 sodium hydroxide water for injection - invega sustenna® is indicated for the acute and maintenance treatment of schizophrenia in adults.