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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

advanz pharma - baclofen - oral solution - 1mg/1ml

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

arrotex pharmaceuticals pty ltd - sulfamethoxazole, quantity: 32.922 mg/g; trimethoprim, quantity: 6.584 mg/g - oral liquid, suspension - excipient ingredients: methyl hydroxybenzoate; sodium benzoate; carmellose sodium; sorbitol; dispersible cellulose; glycerol; polysorbate 80; ethanol; sunset yellow fcf; allura red ac; saccharin sodium; citric acid; purified water; flavour - indications as at 01 march 2002 : upper and lower respiratory tract infections; renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias, and other infections caused by sensitive organisms.

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

norgine pty ltd - sodium ascorbate, quantity: 48.11 g; ascorbic acid, quantity: 7.54 g - solution, powder for - excipient ingredients: - bowel cleansing prior to any procedure requiring a clean bowel.

European Union - English - EMA (European Medicines Agency)

valneva sweden ab - recombinant cholera toxin b subunit, vibrio cholerae 01 - cholera; immunization - vaccines - dukoral is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.the use of dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.dukoral should not replace standard protective measures. in the event of diarrhoea measures of rehydration should be instituted.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

valneva uk ltd - vibrio cholerae - oral suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

irish botanica - valerian tincture 1:2 60% - oral solution - .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ciclosporin - oral solution - 100mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ciclosporin - oral capsule - 10mg