Oxapex: Withdrawal of the marketing authorisation application

An application for the granting of a community marketing authorisation for Oxapex was submitted to the European Medicines Agency on 28 September 2010 by New A Innovation (NL) Limited B.V., a recognised small-and-medium-sized-enterprises (SME) company, in accordance with Regulation (EC) No. 726/2004. The product was eligible for the centralised procedure under Article 3.2 of Regulation (EC) No 726/2004 as the product contains a new active substance, which was not authorised in the Community on the date of entry into force of the Regulation. Oxapex was classified as a minor use, minor species (MUMS) product. Reduced data requirements therefore did apply.Oxapex contains modified and stabilised haemoglobin (65 mg/ml) and is presented in EVA-multi-layer infusion bags of 100 ml. It was indicated to provide immediate oxygen-carrying support improving the clinical signs of anaemia in dogs for at least 24 hours, independent of the underlying condition. The route of administration is intravenous use. The target species is dogs.The application was validated on 12 October 2010 and the assessment was carried out by the Committee for Medicinal Products for Veterinary Use (CVMP) in line with its normal timetable. In response to questions, supplementary information was provided by the applicant on 14 October 2011, and oral and written explanations were given by the applicant on 8 March 2012. At Day 180 of the procedure, the CVMP considered on the basis of quality, safety and efficacy data submitted, that the product was not approvable, since major objections had been identified, which precluded a recommendation for marketing authorisation. The concerns were mainly in relation to the efficacy of the product.On 13 March 2012, New A Innovation (NL) Limited B.V. withdrew the application at day 180 of the procedure. In its letter notifying the Agency of the withdrawal of application, the company stated the reason for the withdrawal: CVMP considered that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.