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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2025)

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Date Nonproprietary name Detailed information on revisions of PRECAUTIONS
(from MHLW)		 Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable)
May 20, 2025
  • Acetazolamide
  • Acetazolamide sodium
 PRECAUTIONS
[15.0 KB]		 Summary of Investigation
[87.6 KB]
  • Trichlormethiazide
  • Benzylhydrochlorothiazide
  • Irbesartan/Trichlormethiazide
 PRECAUTIONS
[13.1 KB]		 Summary of Investigation
[87.6 KB]
  • Hydrochlorothiazide
 PRECAUTIONS
[14.0 KB]		 Summary of Investigation
[87.6 KB]
  • Mefruside
 PRECAUTIONS
[12.6 KB]		 Summary of Investigation
[87.6 KB]
  • Indapamide
 PRECAUTIONS
[60.2 KB]		 Summary of Investigation
[87.6 KB]
  • Candesartan cilexetil/

hydrochlorothiazide

 PRECAUTIONS
[14.1 KB]		 Summary of Investigation
[87.6 KB]
  • Telmisartan/amlodipine besilate/

hydrochlorothiazide

  • Telmisartan/hydrochlorothiazide
 PRECAUTIONS
[14.3 KB]		 Summary of Investigation
[87.6 KB]
  • Valsartan/hydrochlorothiazide
 PRECAUTIONS
[14.1 KB]		 Summary of Investigation
[87.6 KB]
  • Losartan potassium/

hydrochlorothiazide

 PRECAUTIONS
[14.1 KB]		 Summary of Investigation
[87.6 KB]
  • Riociguat
 PRECAUTIONS
[18.5 KB]		 Report on Deliberation/
Report on Investigation
[724 KB]
  • Domperidone (oral dosage form, suppository)
 PRECAUTIONS
[20.6 KB]		 Report on Investigation
[148 KB]
Appendix 4 is not included in this file. See Detailed information on revisions of PRECAUTIONS.
  • Ceritinib
 PRECAUTIONS
[14.6 KB]		 Summary of Investigation
[56.0 KB]
  • Venetoclax
 PRECAUTIONS
[26.4 KB]		 Summary of Investigation
[56.0 KB]
  • Borofalan (10B)
 PRECAUTIONS
[12.6 KB]		 Summary of Investigation
[136 KB]
  • Nemolizumab

(genetical recombination)

 PRECAUTIONS
[12.4 KB]		 Summary of Investigation
[55.1 KB]
  • Eplerenone
 PRECAUTIONS
[16.0 KB]		 Summary of Investigation
[105 KB]
  • Posaconazole (oral dosage form, injections)
 PRECAUTIONS
[16.6 KB]		 Summary of Investigation
[105 KB]
  • Voriconazole (oral dosage form, injections)
 PRECAUTIONS
[20.6 KB]		 Summary of Investigation
[105 KB]

Report on Deliberation/
Report on Investigation
[724 KB]
  • Itraconazole
 PRECAUTIONS
[20.7 KB]		 Report on Deliberation/
Report on Investigation
[724 KB]
  • Iodixanol
 PRECAUTIONS
[20.8 KB]		 Summary of Investigation
[55.7 KB]
April 8, 2025
  • Desmopressin acetate hydrate (injections)
 PRECAUTIONS
[17.7 KB]		 Summary of Investigation
[84.7 KB]
  • Imeglimin hydrochloride
 PRECAUTIONS
[42.2 KB]		 Summary of Investigation
[66.0 KB]
  • Enzalutamide
 PRECAUTIONS
[20.8 KB]		 Summary of Investigation
[62.2 KB]
  • Nirmatrelvir/ritonavir
 PRECAUTIONS
[24.7 KB]		 Summary of Investigation
[62.2 KB]


Note) "Important Safety Information" in Pharmaceuticals and Medical Devices Safety Information (PMDSI)