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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS1This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are
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Xospata (inn-gilteritinib) EPAR refers to the European Public Assessment Report for the drug gilteritinib, which is used for the treatment of certain types of acute myeloid leukemia.
The marketing authorization holder of gilteritinib is required to file the EPAR with the relevant regulatory authority.
The EPAR should be filled out in accordance with the guidelines provided by the European Medicines Agency, including detailed information on the clinical studies, efficacy, safety, and manufacturing processes of gilteritinib.
The purpose of the EPAR is to provide comprehensive information about the medicinal product, including its benefits, risks, and the rationale for its approval in the European Union.
The EPAR must report clinical trial results, pharmacokinetics and pharmacodynamics, safety data, and information regarding the production and quality control of gilteritinib.
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