https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=08E7ACEA-6523-4E8A-B897-9D9522090D6B
衛部藥輸字 第028474號
有效日期：117-05-18
Supported by positive real‑world evidence and endorsed by Taiwan CDC experts as a preferred therapy since 2023, Paxlovid has benefited over 1.87 million patients in Taiwan by September 2025. Its IP covers 68+ countries, with licensing enabling access in 95 low‑ and middle‑income countries.
Manufacturing has been optimized, shortening supply timelines from 6 months to 17 days. Localized packaging, education, and traceability support adherence and management.
Pfizer Taiwan has implemented a risk management plan, providing ongoing education and prescribing guidance to healthcare professionals on drug–drug interactions and appropriate dose adjustments. Educational materials are also supplied to support patient counseling and enhance treatment adherence.
Pfizer Taiwan has implemented a risk management plan and continues post‑marketing safety surveillance. Positive outcomes have been demonstrated in global and Taiwan real‑world studies, and since 2023, it has been consistently recommended by Taiwan CDC expert committees as a preferred COVID‑19 treatment. As of September 2025, it has benefited over 1.87 million patients in Taiwan.
Hammond J et al. N Engl J Med. 2022 Apr 14;386(15):1397-1408.
PAXLOVID has been granted patent authorization in 68 countries, including Taiwan, Singapore, Japan, South Korea, China, Macau, Australia, New Zealand, Malaysia, South Africa, OAPI, Europe, Canada, the United States, and Russia, with many other countries' applications still in progress. Considering the accessibility of
PAXLOVID in low- and middle-income countries, Pfizer signed an agreement with the United Nations-supported Medicines Patent Pool (MPP) in December 2021. By March 2022, 35 generic drug manufacturers had signed agreements with MPP to produce low-cost nirmatrelvir/ritonavir oral medications, helping 95 low- and middle-income countries.
Pfizer continues clinical innovation (35 studies by 2025), expanding use to severe renal impairment and other populations.
