Surfaxin:

Withdrawal of the marketing authorisation application

sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid

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.

  • List item

    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

  • Key facts

    Name
    Surfaxin
    Product number
    EMEA/H/C/000625
    International non-proprietary name (INN) or common name
    • sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid
    Active substance
    • sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid
    Date of withdrawal
    07/06/2006
    Company making the application
    Pharm Research Associates (UK) Limited
    Withdrawal type
    Initial authorisation

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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