Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information: the regulatory dossier on Teslascan (mangafodipir), a contrast agent for liver MRI that was withdrawn from the market in 2012 and that has lost patent protection. Such information is essential for our company to enable generic manufacture of Teslascan for testing in a new clinical trial and ensuing development towards a market authorisation for a novel indication.
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