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Drug firm Guerbet has informed the EMEA that it wishes to withdraw its application for a centralised marketing authorisation for Sinerem.
The drug 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 company had submitted an application for marketing authorisation for Sinerem to the EMEA on October 26, 2006.
At the time of the withdrawal, it was under review by the EMEA’s Committee for Medicinal Products for Human Use (CHMP).
In its official letter, Guerbet said its decision is based on the fact that the CHMP considered that the main study used to evaluate the benefit-risk profile of the medicine failed to statistically demonstrate the efficacy of the drug.
The EMEA said more information about Sinerem and the state of the scientific assessment at the time of withdrawal will be made available shortly.
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