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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2026)

Date Nonproprietary name Information on revisions of PRECAUTIONS
(from MHLW)
Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable)
May 21, 2026 ・Avacopan PRECAUTIONS
[97 KB]
Investigation
[62 KB]

Blue Letter
[226 KB]
April 21, 2026
  • Infliximab
    (genetical recombination) and biosimilars
  • Etanercept
    (genetical recombination) and biosimilars
PRECAUTIONS
[26.5 KB]
Summary of Investigation
[73.8 KB]
  • Calcium chloride hydrate (injection)
PRECAUTIONS
[32.4 KB]
Summary of Investigation
[131 KB]
  • Calcium gluconate hydrate
PRECAUTIONS
[31.4 KB]
Summary of Investigation
[131 KB]
  • Avelumab
    (genetical recombination)
PRECAUTIONS
[25.6 KB]
Summary of Investigation
[79.8 KB]
  • Regorafenib hydrate
PRECAUTIONS
[25.6 KB]
Summary of Investigation
[78.6 KB]