European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. (miol) - febuxostat - gout - antigout preparations - 80 mg strength:treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).adenuric is indicated in adults.120 mg strength:adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).adenuric is indicated in adults.

European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - avanafil - erectile dysfunction - drugs used in erectile dysfunction - treatment of erectile dysfunction in adult men.in order for spedra to be effective, sexual stimulation is required.

European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. (miol) - ranolazine - angina pectoris - cardiac therapy - ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,

European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4.2, 4.4 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - meropenem trihydrate, vaborbactam - urinary tract infections; bacteremia; bacterial infections; respiratory tract infections; pneumonia; pneumonia, ventilator-associated - antibacterials for systemic use, - vaborem is indicated for the treatment of the following infections in adults:complicated urinary tract infection (cuti), including pyelonephritiscomplicated intra-abdominal infection (ciai)hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap).treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.vaborem is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Singapore - English - HSA (Health Sciences Authority)

a. menarini asia-pacific holdings pte. ltd. - pathology - the cellsearch® circulating tumor cell kit is intended for the enumeration of circulating tumor cells (ctc) of epithelial origin (cd45-, epcam+, and cytokeratins 8, 18+, and/or 19+) in whole blood. the presence of ctc in the peripheral blood, as detected by the cellsearch® circulating tumor cell kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate cancer. the test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. serial testing for ctc should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. evaluation of ctc at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

Ireland - English - HPRA (Health Products Regulatory Authority)

menarini international operations luxembourg s.a. - calcium phosphate; cholecalciferol - powder for oral suspension - 1200 mg/800 international unit(s) - calcium, combinations with vitamin d and/or other drugs

Ireland - English - HPRA (Health Products Regulatory Authority)

menarini international operations luxembourg s.a. - calcium phosphate; cholecalciferol - powder for oral suspension - 1200mg/800 international unit(s) - calcium, combinations with vitamin d and/or other drugs

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

a. menarini farmaceutica internazionale srl - ranolazine - modified-release tablet - 500mg

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

a. menarini farmaceutica internazionale srl - ranolazine - modified-release tablet - 375mg