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CPAC 'Reducing PMS cases for Zerbaxa deemed valid'

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

23.04.20 12:05:02

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CPAC votes to reduce the no. of surveillance cases from 3000 to 460, and the surveillance period to 6+4




Experts in Korea have agreed that it is valid for MSD Korea to change its post-marketing surveillance plan for ¡®Zerbaxa inj (ceftolozane/tazobactam),¡¯ which is used to treat severe multidrug-resistant Pseudomonas aeruginosa infections, in consideration of its usefulness and usage.

The biggest reason was due to the company¡¯s difficulty in collecting cases for surveillance caused by its low use due to long-term out-of-stock status, reimbursement restrictions after receiving marketing authorization, and a voluntary recall measure.

According to the minutes of the Central Pharmaceutical Affairs Council that was recently disclosed by the Ministry of Food and Drug Safety, the CDDC de

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