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Abnormal cases of Inlyta in PMS for 9 yrs is 82.8%

By Lee, Hye-Kyung | translator Choi HeeYoung

22.06.22 12:01:21

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A post-marketing survey of 111 people for re-examination

The MFDS to change permission as of September 21st


As a result of a post-marketing survey of Korea Pfizer Pharmaceutical's kidney cancer treatment Inlyta, the incidence of abnormal cases was 82.88% regardless of the causal relationship. As a result of conducting PMS on 111 people over 9 years for re-examination, 92 people (338 cases in total) showed abnormal cases regardless of causality.

Among them, 7.31% of the serious adverse drug reactions that cannot be excluded from the causal relationship and 14.41% of the unexpected adverse drug reactions.

The MFDS announced that it plans to reflect it from September 21st after completing a preliminary notice of changes to permits according to the results of PMS. Serious drug adverse reactions in

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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