Sinerem: Withdrawal of the marketing authorisation application
On 13 December 2007, Guerbet officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sinerem, intended for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Sinerem (PDF/89.8 KB)Adopted
First published: 17/04/2008
Last updated: 17/04/2008
Guerbet withdraws its marketing authorisation application for Sinerem (PDF/24 KB)
First published: 14/12/2007
Last updated: 14/12/2007
Withdrawal letter : Sinerem (PDF/101.75 KB)
First published: 13/12/2007
Last updated: 13/12/2007
Questions and answers on the withdrawal of the marketing application for Sinerem (PDF/39.17 KB)
First published: 24/01/2008
Last updated: 24/01/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').