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The pharmaceuticalcompany also highlighted that the decision was additionally supported by data from a subpopulation of adult patients with moderate to severe anaemia from the SIMPLIFY-1 Phase III trial. GSK shared that a decision on marketing authorisation for momelotinib in the EU is expected by early 2024.
It also allows pharmaceuticalcompanies to monitor product information and keep it constantly updated, as well as offering healthcare professionals and patients greater accessibility. Pharmaceuticalcompanies participating in the pilot create and submit the ePI via the PLM Portal as part of their regulatory application.
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