The European Medicines Agency (EMA) information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a human medicine.
It includes withdrawals of new marketing authorisation applications or for changes to existing marketing authorisations, which are evaluated by the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). When an application is withdrawn after the first stage of evaluation by the CHMP or CVMP, a withdrawal assessment report is published. Search for:
For more information, see: