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The European Medicines Agency's Committee for Medicinal Productsfor Human Use (CHMP) has concluded that the benefits of the fourfibrates bezafibrate, ciprofibrate, fenofibrate and gemfibrozil continue to outweigh their risks in the treatmentof patients with blood lipid disorders. However, doctors should notprescribe them to newly-diagnosed patients with blood lipiddisorders as first-line treatment, except for patients with severehypertriglyceridaemia or patients who cannot take statins. Fibrates are a class of medicines that have been in use for manyyears to lower level of lipids such as triglycerides and cholesterol in the blood. They were first subject to a Europe-wide review in2005, when the CHMP's Pharmacovigilance Working Party reviewedtheir benefits and risks because of limited evidence of theirlong-term benefits in reducing cardiovascular risks. At that timethe Working Party concluded that these medicines continued to havea place in the treatment of lipid disorders but should not be usedas first-line treatment. The current review by the CHMP was initiated at the request of theUnited Kingdom, because a number of marketing authorisation holdersof the four fibrates had questioned the conclusions of thePharmacovigilance Working Party. The UK therefore referred thematter to the CHMP for adoption of a Europe-wide recommendationwhether the existing marketing authorisations should be maintainedor changed. The Committee confirmed the conclusions of the PharmacovigilanceWorking Party and recommended that fibrate-containing medicinesshould not be used as first-line treatment, except in patients withsevere hypertriglyceridaemia and in patients who cannot usestatins. For fenofibrate, the Committee noted additional new dataand recommended that it can also be used together with a statin insome circumstances when a statin on its own has not been enough tocompletely control blood lipid levels. The CHMP's opinion has been sent to the European Commission for theadoption of a binding decision throughout the European Union. Notes 1. There are four fibrates available in the European Union.Bezafibrate is marketed mainly under the trade names Bezalip,Cedur, Eulitop and Befizal; ciprofibrate is marketed mainly underthe trade name Lipanor; fenofibrate is marketed mainly under thetrade name Lipanthyl; gemfibrozil is marketed mainly under thetrade name Lopid. All of these medicines are also available asgeneric medicines. 2. This review was initiated under Article 31 of Directive2001/83/EC, as amended. This type of procedure may be initiated inspecific cases where the interest of the Community is involved. Theexpression 'Community interest' has a broad meaning but it refersparticularly to the interests of the public health in theCommunity, for example following concerns related to the quality,efficacy and/or safety of a medicinal product, which is authorisedat the level of the Member States. Source: European Medicines Agency. I am an expert from custompackagingbags.com, while we provides the quality product, such as Printed Polythene Bags Manufacturer , China Drawstring Plastic Bags, Custom Printed Shopping Bags,and more.
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