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News Breaks
October 3, 2012
07:31 EDTACRXAcelRX receives notice of eligibility for review for Sufentanil NanoTab system
AcelRx Pharmaceuticals announced a decision by the European Medicines Agency to permit registration of the Sufentanil NanoTab PCA System (ARX-01) via the centralized procedure under Article 3(2) (b) of Regulation EC 726/2004. This procedure will allow AcelRx to submit a single Marketing Authorization Application to the EMA for approval to market ARX-01 in all 27 European Union, or EU, member states, as well as in the 4 European Free Trade Association, or EFTA, countries, through a single evaluation that will be carried out through the Committee for Medicinal Products for Human Use.
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