Withdrawal of the marketing authorisation application
On 7 June 2006, Pharm Research Associates (UK) Limited has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their marketing application for SURFAXIN, for the prevention and treatment of respiratory distress syndrome (RDS) in premature babies. SURFAXIN was designated as an 'orphan medicine' on 29 July 2004.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Surfaxin (PDF/130.8 KB)Adopted
First published: 26/07/2006
Last updated: 26/07/2006
Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for Surfaxin (PDF/24.04 KB)
First published: 08/06/2006
Last updated: 08/06/2006
Withdrawal letter : Surfaxin (PDF/41 KB)
First published: 06/06/2006
Last updated: 06/06/2006
Questions and answers on withdrawal of marketing application for Surfaxin (PDF/46.13 KB)
First published: 29/06/2006
Last updated: 29/06/2006
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').