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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)
August 17, 2026
  • Donanemab
    (genetical recombination)
PRECAUTIONS
[51.1 KB]
Summary of Investigation
[38.4KB]
  • Lecanemab
    (genetical recombination)
PRECAUTIONS
[63.5 KB]
Summary of Investigation
[38.4KB]
July 14, 2026
  • Esomeprazole Magnesium Hydrate
  • Omeprazole
  • Vonoprazan Fumarate
  • Rabeprazole Sodium
  • Lansoprazole (oral dosage form)
PRECAUTIONS
[57.1 KB]
Summary of Investigation
[136KB]
  • Omeprazole Sodium
  • Lansoprazole (injection)
PRECAUTIONS
[57.8KB]
Summary of Investigation
[136 KB]
  • Insulin aspart
    (genetical recombination)
    (Fiasp Injection 100U/mL)
PRECAUTIONS
[103 KB]
Summary of Investigation
[99.4 KB]
  • Aspirin/
    Vonoprazan Fumarate
PRECAUTIONS
[56KB]
Summary of Investigation
[136 KB]
  • Aspirin/Lansoprazole
PRECAUTIONS
[64.1 KB]
Summary of Investigation
[136 KB]
  • Guselkumab
    (Genetical Recombination)
PRECAUTIONS
[134 KB]
Summary of Investigation
[128KB]
  • Doxorubicin hydrochloride
    (liposome formulations)
PRECAUTIONS
[61.1 KB]
Summary of Investigation
[62.3 KB]
  • Atezolizumab
    (Genetical Recombination)
  • Avelumab
    (Genetical Recombination)
  • Ipilimumab
    (Genetical Recombination)
  • Cemiplimab
    (Genetical Recombination)
  • Tislelizumab
    (Genetical Recombination)
  • Durvalumab
    (Genetical Recombination)
  • Tremelimumab
    (Genetical Recombination)
  • Nivolumab
    (Genetical Recombination)
  • Retifanlimab
    (Genetical Recombination)
PRECAUTIONS
[61.5 KB]
Summary of Investigation
[95.6KB]
  • Ixazomib Citrate
PRECAUTIONS
[60.9 KB]
Summary of Investigation
[54.4 KB]
  • Carboplatin
PRECAUTIONS
[58.6 KB]
Summary of Investigation
[55.8 KB]
  • Nivolumab
    (Genetical Recombination)
PRECAUTIONS
[60.5 KB]
Summary of Investigation
[62.3 KB]
  • Vonoprazan Fumarate/
    Amoxicillin Hydrate/Clarithromycin
  • Vonoprazan Fumarate/
    Amoxicillin Hydrate/Metronidazole
PRECAUTIONS
[70.7 KB]
Summary of Investigation
[136 KB]
  • Recombinant RS virus vaccine (Abrysvo)
  • Recombinant RS virus vaccine (Arexvy)
PRECAUTIONS
[110 KB]
Summary of Investigation
[103 KB]
  • Anti-human thymocyte immunoglobulin, rabbit
PRECAUTIONS
[120 KB]
Summary of Investigation
[109KB]
  • Preparations containing omeprazole
    (guidance-mandatory drugs)
PRECAUTIONS
[79.9KB]
Summary of Investigation
[30.3 KB]
  • Preparations containing rabeprazole sodium
    (guidance-mandatory drugs)
PRECAUTIONS
[81.4 KB]
Summary of Investigation
[30.3 KB]
  • Preparations containing lansoprazole
    (guidance-mandatorydrugs)
PRECAUTIONS
[80.9KB]
Summary of Investigation
[30.3 KB]
June 30, 2026
  • Cefcapene pivoxil hydrochloride hydrate
PRECAUTIONS
[51.4 KB]
Summary of Investigation
[93.9 KB]
  • Cefditoren pivoxil
PRECAUTIONS
[51.3 KB]
Summary of Investigation
[93.9 KB]
  • Cefteram pivoxil
PRECAUTIONS
[51.2 KB]
Summary of Investigation
[93.9 KB]
  • Tebipenem pivoxil
PRECAUTIONS
[51.3 KB]
Summary of Investigation
[93.9 KB]
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
[26.5KB]
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]