United States - English - NLM (National Library of Medicine)

aralez pharmaceuticals us inc. - vorapaxar sulfate (unii: in66038e6c) (vorapaxar - unii:zce93644n2) - vorapaxar 2.08 mg - zontivity ® is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (mi) or with peripheral arterial disease (pad). zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, mi, stroke, and urgent coronary revascularization (ucr). zontivity is contraindicated in patients with a history of stroke, tia, or ich because of an increased risk of ich in this population [see adverse reactions (6)] . discontinue zontivity in patients who experience a stroke, tia, or ich [see adverse reactions (6.1) and clinical studies (14)] . zontivity is contraindicated in patients with active pathological bleeding such as ich or peptic ulcer [see warnings and precautions (5.1) and adverse reactions (6.1)] . risk summary based on the potenti

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - vorapaxar sulfate (unii: in66038e6c) (vorapaxar - unii:zce93644n2) - vorapaxar 2.08 mg

European Union - English - EMA (European Medicines Agency)

merck sharp dohme limited - vorapaxar sulfate - myocardial infarction - antithrombotic agents - zontivityis indicated for the reduction of atherothrombotic events in adult patients with- a history of myocardial infarction (mi)co-administered with acetylsalicylic acid (asa) and, where appropriate, clopidogrel; or- symptomatic peripheral arterial disease(pad), co-administered with acetylsalicylic acid (asa) or, where appropriate, clopidogrel.

Canada - English - Health Canada

xspire pharma, llc - vorapaxar sulfate - tablet - 2.5mg - vorapaxar sulfate 2.5mg - platelet aggregation inhibitors

United States - English - NLM (National Library of Medicine)

wraser pharmaceuticals, llc - vorapaxar sulfate (unii: in66038e6c) (vorapaxar - unii:zce93644n2) - zontivity ® is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (mi) or with peripheral arterial disease (pad). zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, mi, stroke, and urgent coronary revascularization (ucr). zontivity is contraindicated in patients with a history of stroke, tia, or ich because of an increased risk of ich in this population [see adverse reactions (6)] . discontinue zontivity in patients who experience a stroke, tia, or ich [see adverse reactions (6.1) and clinical studies (14)] . zontivity is contraindicated in patients with active pathological bleeding such as ich or peptic ulcer [see warnings and precautions (5.1) and adverse reactions (6.1)] . risk summary based on the pote

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 - apo-itraconazole 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.