Oxapex: Withdrawal of the marketing authorisation application

modified and stabilized haemoglobin

Overview

On 26 April 2013 the applicant New A Innovation (NL) Limited B.V. submitted an application for a marketing authorisation to the European Medicines Agency (EMA) for Oxapex solution for infusion in accordance with Regulation (EC) No 726/2004.The eligibility to the centralised procedure was agreed upon by the CVMP on 13 September 2012 as falling under Article 3(2)(a) of Regulation (EC) No 726/2004 as the active substance was not authorised in the community on the date of entry into force of the Regulation. The rapporteur appointed was R. Breathnach and the co-rapporteur was F. Hasslung Wikström.The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC.Oxapex is a solution for intravenous infusion containing 65 mg/ml modified and stabilised hemoglobin (Hb) as the active substance. The product was to bepresented in multi-layered infusion bags containing 100 ml. Two bags would have been included per outer pack (cardboard box). The product was to be administered to dogs by intravenous infusion.The applicant initially applied for the following indication: 'For the treatment of oxygen debt in dogs caused by haemorrhage and haemorrhagic shock and the minimisation of the time to oxygen debt resolution'.On 4 December 2014, New A Innovation (NL) Limited B.V. withdrew the application at day 204 of the procedure. In its letter notifying the EMA of the withdrawal of application, the applicant stated the reason for the withdrawal was based on the strategic decision to supply new data from an additional efficacy study that could not be introduced in the on-going procedure.

Key facts

Name
Oxapex
Product number
EMEA/V/C/002794
International non-proprietary name (INN) or common name
  • modified and stabilized haemoglobin
Active substance
  • modified and stabilized haemoglobin
Date of withdrawal
04/12/2014
Company making the application
New A Innovation (NL) Limited B.V.
Withdrawal type
Initial authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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