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

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.28 mg (equivalent: fingolimod, qty 0.25 mg) - capsule, hard - excipient ingredients: mannitol; hyprolose; hydroxypropylbetadex; magnesium stearate; shellac; iron oxide black; propylene glycol; gelatin; strong ammonia solution; titanium dioxide; iron oxide yellow - fingolimod sandoz is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

novartis pharmaceuticals australia pty ltd - fingolimod hydrochloride, quantity: 0.28 mg (equivalent: fingolimod, qty 0.25 mg) - capsule, hard - excipient ingredients: mannitol; hyprolose; hydroxypropylbetadex; magnesium stearate; shellac; iron oxide black; propylene glycol; gelatin; strong ammonia solution; titanium dioxide; iron oxide yellow - gilenya is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: mannitol; iron oxide yellow; magnesium stearate; gelatin; titanium dioxide - fingolimod sandoz is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

novartis pharmaceuticals australia pty ltd - fingolimod hydrochloride, quantity: 0.28 mg (equivalent: fingolimod, qty 0.25 mg) - capsule, hard - excipient ingredients: mannitol; hyprolose; hydroxypropylbetadex; magnesium stearate; shellac; iron oxide black; propylene glycol; gelatin; strong ammonia solution; titanium dioxide; iron oxide yellow - filosir is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

novartis pharmaceuticals australia pty ltd - fingolimod hydrochloride, quantity: 0.28 mg (equivalent: fingolimod, qty 0.25 mg) - capsule, hard - excipient ingredients: mannitol; hyprolose; hydroxypropylbetadex; magnesium stearate; shellac; iron oxide black; propylene glycol; gelatin; strong ammonia solution; titanium dioxide; iron oxide yellow - fynefta is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriconazole wockhardt is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

nutrition care pharmaceuticals pty ltd - nicotinamide mononucleotide, quantity: 160 mg; nicotinic acid, quantity: 10 mg; quercetin, quantity: 20 mg; ganoderma lucidum, quantity: 20 mg (equivalent: ganoderma lucidum, qty 200 mg); nicotinamide, quantity: 50 mg; curcumin, quantity: 3.6 mg - capsule, hard - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hypromellose; titanium dioxide; potassium citrate; gellan gum; sodium lauryl sulfate; macrogol 400; betadex

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

ax pharmaceutical corp - betadex sulfobutyl ether sodium (unii: 2pp9364507) (betadex - unii:jv039jzz3a) -