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

janssen-cilag pty ltd - itraconazole, quantity: 100 mg - capsule, hard - excipient ingredients: macrogol 20000; titanium dioxide; gelatin; hypromellose; indigo carmine; erythrosine; maize starch; sucrose - sporanox is indicated for use in adults for the treatment of: superficial dermatomycoses not responding to topical treatment. fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. pityriasis versicolor not responding to any other treatment. vulvovaginal candidiasis not responding to topical treatment. oral candidiasis in immunocompromised patients. onychomycosis caused by dermatophytes. systemic mycoses: -systemic aspergillosis, histoplasmosis, sporotrichosis. -treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. -treatment of oropharyngeal and/or oesophageal candidiasis when fist line systemic antifungal therapy is inappropriate or has proven ineffective. -treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology,

Ireland - English - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - itraconazole - concentrate and solvent for solution for infusion - 10 milligram(s)/millilitre - triazole derivatives; itraconazole

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

johnson & johnson sdn bhd - itraconazole -

Malta - English - Medicines Authority

istituto biochimico italiano g. lorenzini s.p.a via fossignano 2, aprilia (lt), italy - voriconazole - powder for solution for infusion - voriconazole 200 mg - antimycotics for systemic use

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100,0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - voriconazole 200mg - powder for injection - 200 mg - active: voriconazole 200mg excipient: sulfobutyl betadex sodium water for injection - voriconazole - aft is indicated for the following fungal infections: invasive aspergillosis serious candida infections (including c. krusei), including systemic candida 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.

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

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - the primary use of the cobas? 4800 braf v600 mutation test is the detection of the braf v600 mutations in dna extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (ptc) tissue. in melanoma, it is intended to be used as an aid in selecting patients whose tumors carry braf v600 mutations for treatment either with zelboraf? (vemurafenib) alone, or with cotellic? (cobimetinib) in combination with zelboraf? (vemurafenib). ivds that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Ireland - English - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - itraconazole - oral solution - triazole derivatives; itraconazole

Ireland - English - HPRA (Health Products Regulatory Authority)

hameln pharma gmbh - voriconazole - powder for solution for infusion - voriconazole