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Guerbet Withdraws Its Marketing Authorisation Application For Sinerem
The European Medicines Agency (EMEA) has been formally notified by
Guerbet of its decision to withdraw its application for a centralised
marketing authorisation for the medicine Sinerem (superparamagnetic iron
oxide nanoparticles stabilised with dextran and sodium citrate).
Sinerem was expected to be used for the characterisation of lymph nodes
visualised with magnetic resonance imaging in the evaluation of primary
tumour spread in pelvic cancers.
The application for marketing authorisation for Sinerem was submitted to
the EMEA on 26 of October 2006. At the time of the withdrawal, it was
under review by the Agency's Committee for Medicinal Products for Human
Use (CHMP).
In its official letter, the company stated that the withdrawal of
Sinerem was based on the information that the CHMP considered that the
main study used to evaluate the benefit-risk profile of the medicine had
failed to statistically demonstrate the efficacy of Sinerem.
More information about Sinerem and the state of the scientific
assessment at the time of withdrawal will be made available in a
question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website shortly.
Withdrawal of an application does not prejudice the possibility of a
company making a new application at a later stage.
http://www.emea.europa.eu
Guerbet retrage cererea de autorizaþie de comercializãrii Pentru Sinerem - Guerbet Withdraws Its Marketing Authorisation Application For Sinerem - articole medicale engleza - startsanatate