OraNera:

Withdrawal of the marketing authorisation application

multilayered cell-sheet of autologous oral mucosal epithelial cells

Overview

On 14 March 2013, CellSeed Europe Ltd. officially notified the European Medicines Agency that it wishes to withdraw its application for a marketing authorisation for OraNera (previously known as Caomecs), intended for the treatment of limbal-stem-cell deficiency in adults.

Key facts

Name
OraNera
Product number
EMEA/H/C/002443
International non-proprietary name (INN) or common name
  • multilayered cell-sheet of autologous oral mucosal epithelial cells
Active substance
  • multilayered cell-sheet of autologous oral mucosal epithelial cells
Date of withdrawal
14/03/2013
Company making the application
CellSeed Europe Ltd
Withdrawal type
Initial authorisation

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP'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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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