Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-372-250"

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"en.20120911.32.2-372-250"2
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"At the end of 2010, the European Parliament and the Council agreed a revision of the rules governing the area of pharmacovigilance at European Union level. Application of this new legislation started in July this year. The measures aim to achieve an improvement in the safety of medicines at European level by strengthening the role of the European Medicines Agency (EMA) in collecting data and enhancing cooperation between Member States. One of the stimuli was the case of the medicine Mediator last year. Mediator was a medicine developed by the French company Servier for the treatment of type 2 diabetes. Its main active ingredient is benfluorex, which can cause heart valve disorders. The adverse effects of this substance have been discussed since the late nineties. The safety of this medicine is still under investigation. Even despite this, it was prescribed to almost 5 million EU citizens up to 2009, mostly in France. The number of deaths related to this medicine is estimated to be up to 2 000. I therefore consider it necessary to reach an agreement with the Council as swiftly as possible that will ensure that similar mistakes are not made again."@en1

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