Surfaxin: Withdrawal of the marketing authorisation application
Table of contents
Overview
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.
Key facts
Name |
Surfaxin |
Product number |
EMEA/H/C/000625 |
Date of withdrawal |
07/06/2006 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Surfaxin (PDF/130.8 KB)
Adopted
First published: 26/07/2006
Last updated: 26/07/2006
EMEA/CHMP/255780/2006 -
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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
EMEA/211505/2006 -
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Withdrawal letter : Surfaxin (PDF/41 KB)
First published: 06/06/2006
Last updated: 06/06/2006 -
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Questions and answers on withdrawal of marketing application for Surfaxin (PDF/46.13 KB)
First published: 29/06/2006
Last updated: 29/06/2006
EMEA/CHMP/220307/2006 -
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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').