AMSTERDAM, February 8, 2018
AMSTERDAM, February 8, 2018 /PRNewswire/ --
Norgine B.V. today announced that the marketing authorisation for PLENVU® for bowel cleansing in adults prior to any procedure requiring a clean bowel, has been granted by the German regulatory authority. The approval was granted under the European decentralised procedure, with the UK as reference state. Norgine anticipates launch of PLENVU® in Germany later this year.
PLENVU® is now approved for use in Australia, Austria, Belgium, Croatia, Denmark, Finland, France, Hungary, Iceland, Ireland, Italy, Norway, Portugal, Romania, The Netherlands and in the UK (using the trademark PLEINVUE™ in Austria and The Netherlands).
PLENVU® is already commercially available in the UK and Belgium.
PLENVU® is a novel, low volume (1-litre) polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing.
The approvals were based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies: MORA, NOCT and DAYB studies.
PLENVU® (NER1006) demonstrated an acceptable safety profile in the NOCT, MORA, and DAYB phase III studies.
Norgine manufactures PLENVU® and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.
Access the full media release on www.norgine.com
Isabelle Jouin, T: +44-(0)1895-453643