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.

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. - pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,

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. - 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.

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)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - community-acquired infections - antibacterials for systemic use, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

a. menarini farmaceutica internazionale srl - dapoxetine - oral tablet - 30mg

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

a menarini australia pty ltd - ferric derisomaltose, quantity: 4170 mg (equivalent: iron, qty mg) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions:- when oral iron preparations are ineffective or cannot be used - where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests.