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

novartis - darifenacin hydrobromide - prolonged-release tablet - 7.5 mg

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

aspen pharma trading limited (aptl), ireland - darifenacin hydrobromide - prolonged-release tablet - 7.5 mg

India - English - Central Drugs Standard Control Organization

summit - darifenacin hbr - tab - 7.5mg - 10

India - English - Central Drugs Standard Control Organization

sun - darifenacin hbr - 15mg - 5*10

India - English - Central Drugs Standard Control Organization

sun - darifenacin hbr - 7.5mg - 5*10

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.

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.