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  • CPAC 'Reducing PMS cases for Zerbaxa deemed valid'
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Apr 21, 2023 05:56am
due to its long-term out-of-stock and reimbursement restriction issues
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 decided to reduce the required n
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