Paccal Vet: Withdrawal of the marketing authorisation application

An application for the granting of a community marketing authorisation for Paccal Vet was submitted to the European Medicines Agency on 31 August 2010 by Oasmia Pharmaceutical AB, a recognised small and medium-sized enterprise (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.Paccal Vet contains paclitaxel as active substance and is presented in single-use containers of one vial. It is indicated for the treatment of non-resectable grade II or III mast cell tumours in dogs. The route of administration is intravenous. The target species is dogs.The application was validated on 14 September 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 9 September 2011, and oral and written explanations were given by the applicant on 7 February 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 and safety of the product.On 2 March 2012, Oasmia Pharmaceuticals AB withdrew the application at day 204 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.