Prosonix’ Marketing Authorisation Application for PSX1001 – a Generic Version of GlaxoSmithKline’s Flixotide® Evohaler® – Under Assessment in EU

02-09-2014 11:41

Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, announces that its Marketing Authorisation Application (MAA) for PSX1001 has been validated and is being assessed under the Decentralised Procedure (DCP), in which the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the Reference Member State. Prosonix has submitted the primary MAA under the DCP and a simultaneous duplicate MAA on behalf of Mylan Inc.

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