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As a result of the PMS of Entresto·Xnepri,

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.04.15 05:50:37

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MFDS prepares a plan to change permits, investigates 3075 people over 6 years



As a result of a post-marketing investigation of the chronic heart failure treatment ingredient 'Sacubitril Valsartan Sodium Hydroxide', the incidence rate of adverse events was 24.62% regardless of the causal relationship.

The MFDS prepares an order (draft) to change permission items based on the results of post-marketing surveillance (PMS) conducted by pharmaceutical companies on 3,075 people for 6 years for re-examination in Korea and proceeds with opinion inquiry by the 28th. do. The items in question are Novartis Korea 'Entresto Film Coated Tab' 50mg, 100mg, and 200mg and Sandoz 'Xnepri Film Coated Tab' 50mg, 100mg, and 200mg, which received product approval on April 14, 2016. As a result of a pos

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