Articles with "extension indication" as a keyword



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Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

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Published in 2021 at "Frontiers in Medicine"

DOI: 10.3389/fmed.2021.790782

Abstract: After marketing authorisation, the development of a medicinal product often continues with studies investigating new therapeutic indications. Positive results can potentially lead to changes to the terms of the marketing authorisation, such as an extension… read more here.

Keywords: european union; extension indication; indication; oncology ... See more keywords