Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

h. lundbeck a.s. - sertindole 4 mg - film-coated tablet - sertindole

Israel - English - Ministry of Health

j-c health care ltd - miconazole - gel - miconazole 20 mg/g - miconazole - miconazole - oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. daktarin oral gel can be used for the prevention of oral thrush in patient receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy.

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

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

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - itracap 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 first 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, insensitivity of the pathogen or drug toxicity.

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

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - itranox 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 first 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, insensitivity of the pathogen or drug toxicity.

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type a; hypromellose phthalate; gelatin; brilliant blue fcf; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: sodium starch glycollate type a; titanium dioxide; brilliant blue fcf; hypromellose phthalate; silicon dioxide; magnesium stearate; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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.

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

janssen-cilag pty ltd - itraconazole, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; flavour - 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.

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,