Horizon scanning: Eziclen®/Izinova® for bowel cleansing completes European decentralised registration procedure

Source: MarketWatch Area: News According to a Market Watch report, the sulphate-based bowel cleansing preparation Eziclen® / Izinova® (containing sodium, magnesium and potassium sulphates) has successfully completed its European decentralised registration procedure involving 16 countries, with launch expected by the end of 2013. The product will be indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel (e.g. bowel visualisation including bowel endoscopy and radiology or surgical procedure). Each Member State (including the UK) should now adopt a national decision within 30 days.   The clinical efficacy and safety of Eziclen® / Izinova® was demonstrated in two randomised, controlled Phase III studies which confirmed the non-inferiority of BLI-800 versus the comparator (a 2 litre polyethylene glycol plus electrolytes solution), with regards to bowel cleansing effectiveness. The product was approved in the US in 2010.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news