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

merck sdn. bhd. - avelumab -

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: capsugel red g60csa00150 colloidal silicon dioxide ethanol gelatin hypromellose iron oxide red methylene chloride opacode white s-1-7078 purified water sorbitan stearate sugar spheres titanium dioxide - itraconazole capsules are indicated for the treatment of: · vulvovaginal candidiasis. · pityriasis versicolor, · dermatomycosis - including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, · fungal keratitis, · oral candidiasis, · onychomycosis caused by dermatophytes and/or yeasts. · systemic mycoses, only in the following fungal infections: - systemic aspergillosis - histoplasmosis, - histoplasmosis, maintenance therapy only in aids patients - sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous) - paraconccidioidomycosis, - chromomycosis, - blastomycosis

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: erythrosine gelatin   hypromellose indigo carmine macrogol 20000 sugar spheres titanium dioxide - sporanox capsules are indicated for the following conditions: - treatment of vulvovaginal candidiasis. - treatment of pityriasis versicolor. - treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - treatment of fungal keratitis. - treatment of oral candidiasis. - treatment of onychomycosis caused by dermatophytes and/or yeasts. - systemic mycoses, only in the following fungal infections: o treatment of systemic aspergillosis and candidiasis, o treatment of histoplasmosis, o histoplasmosis, maintenance therapy only in aids patients. o treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o treatment of paracoccidioidomycosis, o treatment of chromomycosis, o treatment of blastomycosis.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 200mg;  ;   - film coated tablet - 200 mg - active: voriconazole 200mg     excipient: croscarmellose sodium lactose monohydrate magnesium stearate opadry white oy-ls-28914 povidone pregelatinised maize starch purified water   - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 50mg;  ;   - film coated tablet - 50 mg - active: voriconazole 50mg     excipient: croscarmellose sodium lactose monohydrate magnesium stearate opadry white oy-ls-28914 povidone pregelatinised maize starch purified water   - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 200mg;  ;   - powder for injection - 200 mg - active: voriconazole 200mg     excipient: sulfobutyl betadex sodium water for injection - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 40 mg/ml;  ;   - powder for oral suspension - 40 mg/ml - active: voriconazole 40 mg/ml     excipient: citric acid colloidal silicon dioxide orange flavour 57458 ap05514 sodium benzoate sodium citrate dihydrate sucrose titanium dioxide xanthan gum - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

Israel - English - Ministry of Health

j-c health care ltd - itraconazole - solution - itraconazole 10 mg/ml - itraconazole - itraconazole - sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. prevention of fungal infection during neutropenia of immunodeficient patients.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - voriconazole - film coated tablets - voriconazole 50 mg - voriconazole - voriconazole - treatment of:- invasive aspergillosis,- fluconazole-resistant serious invasive candida infections (including c. krusei) - serious fungal infections caused by scedosporium spp. and fusarium spp.- vfend should be administered primarily to immunocompromised patients with progressive possibly life-threatening infections. - treatment of candidemia in non neutropenic patients.- prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.