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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)
June 16, 2026
  • Lithium carbonate
PRECAUTIONS
[65.4 KB]
Report on Investigation
[126 KB]
  • Ferric carboxymaltose
  • Saccharated ferric oxide
PRECAUTIONS
[58.1 KB]

PRECAUTIONS
[58.3 KB]
Summary of Investigation
[24.6 KB]
  • Valemetostat tosilate
PRECAUTIONS
[138 KB]
Summary of Investigation
[43.5 KB]
  • Sulfamethoxazole/trimethoprim
    (oral dosage form)
  • Sulfamethoxazole/trimethoprim (injection)
PRECAUTIONS
[57.3 KB]

PRECAUTIONS
[57.2 KB]
Summary of Investigation
[35.1 KB]
June 5, 2026
  • Donanemab
    (genetical recombination)
PRECAUTIONS
[43.3 KB]
Summary of Investigation
[71.2 KB]
  • Lecanemab
    (genetical recombination)
PRECAUTIONS
[44.4 KB]
Summary of Investigation
[29.9 KB]
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]