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,

Malta - English - Medicines Authority

tad pharma gmbh heinz-lohmann-strasse 5, 27472 cuxhaven, germany - clarithromycin - prolonged-release tablet - clarithromycin 500 mg - antibacterials for systemic use

Malta - English - Medicines Authority

nm pharma limited 3/4, cantrija complex triq it-targa, il-maghtab naxxar nxr 6613 , malta - prolonged-release tablet - clarithromycin 500 mg - antibacterials for systemic use

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.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - itraconazole - solution - 10 mg/ml - itraconazole 10 mg/ml

European Union - English - EMA (European Medicines Agency)

abbvie ltd - ombitasvir / paritaprevir / ritonavir - hepatitis c, chronic - antivirals for systemic use - viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

abbvie ltd - ombitasvir; ritonavir; paritaprevir - tablet - 12.5mg ; 50mg ; 75mg

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

johnson & johnson sdn bhd - itraconazole -

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