marketing authorization application


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marketing authorization application

A complete dossier of information, including chemical, pharmaceutical, biological and clinical data, that is sent to a regulatory authority to support a request for marketing authorisation in the European Community.
References in periodicals archive ?
One of these Phase III drug candidates, Dyloject, is currently under review for Marketing Authorization Application (MAA) approval in Europe.
We are very pleased with Jerini's timely completion of patient randomization for FAST-1 and FAST-2, placing us on track to report top-line data in the third quarter of this year, filing a marketing authorization application by year-end 2006 and projected launch in 2007," said Adrian Adams, President and CEO.
Tercica submitted this updated dataset, which was presented for the first time today at PENS, as part of its Marketing Authorization Application (MAA) for approval to market Increlex in the European Union (EU).
This updated dataset was included in the Marketing Authorization Application (MAA) that Tercica submitted to the European Medicines Agency (EMEA) for approval to market Increlex in the European Union (EU), and has not been previously presented.
today announced that the Marketing Authorization Application (MAA) for ProQuin(R) XR was accepted for review by the Medical Products Agency in Sweden.
NYSE:ACL) announced the withdrawal of its European marketing authorization application (MAA) for RETAANE(R) 30mg/ml (anecortave acetate suspension for depot injection) from The European Medicines Agency (EMEA) review process.
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