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Hetlioz, a melatonin receptor agonist, is indicated for the treatment of non-24-hour sleep-wake disorder ( Non-24 ).Important safety informationHetlioz may cause somnolence. After taking Hetlioz, pati ...


The FDA ( Food and Drug Administration ) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved Testosterone products.FDA has decided to reassess this safety issue bas ...


FDA ( Food and Drug Administration ) has warned that the blood pressure drug Olmesartan Medoxomil ( marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics ) can cause intestinal problems know ...


Azithromycin ( Zithromax, Zmax ) use is associated with an increased risk of death from cardiovascular causes among patients at high baseline risk. Whether azithromycin confers a similar risk in the u ...


The Committee for Medicinal Products for Human Use ( CHMP ) has finalised a review of GLP-1-based diabetes therapies. The Committee concluded that presently available data do not confirm recent concer ...


The Committee on Medicinal Products for Human Use ( CHMP ) has recommended that the marketing authorisations of oral Ketoconazole-containing medicines should be suspended throughout the European Union ...


The Committee on Medicinal Products for Human Use ( CHMP ) has recommended changes to the use of Metoclopramide-containing medicines in the European Union ( EU ), including restricting the dose and du ...


Yervoy ( Ipilimumab ) is indicated for the treatment of unresectable or metastatic melanoma, and can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and prolifera ...


The Committee for Medicinal Products for Human Use ( CHMP ) has recommended a restriction in the use of the osteoporosis medicine Protelos / Osseor, following an assessment of data showing an increase ...


The EMA’s Committee for Medicinal Products for Human Use ( CHMP ) has confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn ( Nicotinic acid / Larop ...


The Pharmacovigilance Risk Assessment Committee ( PRAC ) of European Medicines Agency ( EMA ) has reviewed new information on the cancer medicine Iclusig ( Ponatinib ) that suggests that side effects ...


The Pharmacovigilance Risk Assessment Committee ( PRAC ) of EMA ( European Medicines Agency ) has recommended that medicines containing Acipimox should have their marketing authorisations amended to e ...


The Committee on Human Medicinal Products ( CHMP ) of EMA ( European Medicines Agency ) has recommended that the authorised uses for Thiocolchicoside-containing medicines for use by mouth or injection ...


The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has made a number of recommendations to help minimise the risk of blood clots obstructing arteries or v ...


The Coordination Group for Mutual Recognition and Decentralised Procedures – Human ( CMDh ) has endorsed by consensus a series of risk-minimisation measures to address safety concerns with Codeine-con ...