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The incidence of adverse effects in Alecensa is 80%

By Lee, Hye-Kyung | translator Choi HeeYoung

22.10.06 06:18:12

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The Ministry of Food and Drug Safety inquired about opinions by the 18th to change the permission



A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively. The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th.

Eisai Korea obtained an item license for Fycompa film coated tab on

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