Topiramate ema

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The European Medicines Agency has completed a review of Topamax and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Topamax and associated names in the European Union (EU) and the. In newly diagnosed patients, topiramate showed benefit in monotherapy in two (TOPMAT-EPMN and. TOPMAT-EPMN) out of the three studies conducted. Study TOPMAT-EPMN provided evidence to support the extension to the wider 'epilepsy' indication as this is the only study which included patients.

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