Regulatory Dossier on Teslascan (mangafodipir)

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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the following information: the regulatory dossier on Teslascan (mangafodipir), a contrast agent for liver MRI that was withdrawn from the market in 2012 and that has lost patent protection.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.

Yours faithfully,

Sigrid Fossheim

EMA Info, Agencia Europea de Medicamentos

Dear Sir/Madam,

Thank you for contacting the European Medicines Agency.

Please note that this mailbox is not monitored.

Please refer to the contact page of the European Medicines Agency to find the appropriate contact point for your query.

If you wish to submit a request for access to documents or a general request for information, please resubmit your request via our webform by following the link below:
http://www.ema.europa.eu/ema/index.jsp?c...

Best regards,

The European Medicines Agency

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