Iisrael - inglise - Ministry of Health

boehringer ingelheim israel ltd. - nevirapine - tablets - nevirapine 200 mg - nevirapine - nevirapine - for use in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Euroopa Liit - inglise - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nevirapine - hiv infections - antivirals for systemic use - tablets and oral suspensionviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adults, adolescents, and children of any age.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adolescents and children three years and above and able to swallow tablets.prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsviramune is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected adults, adolescents and children three years and above and able to swallow tablets.prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.most of the experience with viramune is in combination with nucleoside reverse-transcriptase inhibitors (nrtis). the choice of a subsequent therapy after viramune should be based on clinical experience and resistance testing.

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - darunavir - film coated tablet - 400 milligram - protease inhibitors

Euroopa Liit - inglise - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv infections - antivirals for systemic use - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).

Uus-Meremaa - inglise - 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

Uus-Meremaa - inglise - 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.

Uus-Meremaa - inglise - 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.

Euroopa Liit - inglise - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassium - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (hiv‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the insti (integrase strand transfer inhibitor) and nrti (nucleoside reverse transcriptase inhibitor) classes (see sections 4.2, 4.4 and 5.1).

Austraalia - inglise - 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.

Austraalia - inglise - 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.