New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - risdiplam 0.75 mg/ml - powder for oral solution - 750 mcg/ml - active: risdiplam 0.75 mg/ml excipient: ascorbic acid disodium edetate dihydrate isomalt macrogol 600 mannitol sodium benzoate strawberry flavour phs-180152 sucralose tartaric acid - evrysdi is indicated for the treatment of spinal muscular atrophy (sma) in patients aged 2 months and older.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

inova pharmaceuticals (singapore) pte ltd (incorporated in singapore) malaysia branch - imiquimod -

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

chartwell rx, llc - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug

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

genesis specialist care pty ltd - 58022 - radiation therapy bolus, reusable - a pliable, solid, non-sterile, 3d-printed material that has similar properties to water when irradiated and is intended to be applied to the skin to modify radiation at the skin surface or depth. it is designed to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. this is a reusable patient-specific product.

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

calvary health care newcastle ltd - 58022 - radiation therapy bolus, reusable - 3d printed bolus is a pliable, solid, non-sterile, material, made of thermoplastic polymer or polyurethane or equivalent, that has similar properties to water when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. it is designed to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. it is designed to fit specific areas of the patient?s anatomy based on a radiotherapy planning ct scan, and is made using a commercial 3d printing device.

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: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate dihydrate; hydroxypropylbetadex; purified water; flavour; sorbitol; methyl hydroxybenzoate; citric acid; sucrose; glycerol; monobasic sodium phosphate; potassium sorbate - 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: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - 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.

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

american health packaging - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug