Transcription of Public Assessment Report Decentralised Procedure …
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Public Assessment Report Decentralised Procedure …
1 Public Assessment Report Decentralised Procedure Plenvu powder for oral solution (Macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride) Procedure No: UK/H/6370/001/DC UK Licence No: PL 20142/0020 Norgine PAR Plenvu powder for oral solution UK/H/6370/001/DC 2 LAY SUMMARY Plenvu powder for oral solution This is a summary of the Public Assessment Report (PAR) for Plenvu powder for oral solution (PL 20142/0020; UK/H/6370/001/DC). It explains how Plenvu powder for oral solution was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Plenvu powder for oral solution. The product will be referred to Plenvu throughout the remainder of this Public Assessment Report (PAR). For practical information about using Plenvu, patients should read the package leaflet or contact their doctor or pharmacist.
PAR Plenvu powder for oral solution UK/H/6370/001/DC 5 I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Member States considered that the application for Plenvu (PL 20142/0020; UK/H/6370/001/DC) could be approved.
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