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Revisions of PRECAUTIONS (FY2023)

Posted date Nonproprietary name
(Click on each drug name for more information
[only available in Japanese language])		 Detailed information on revisions of PRECAUTIONS
(from MHLW)		 Summary of
investigation results
(from PMDA)		 Reference article (Important Safety Information) in Pharmaceuticals and Medical Devices Safety Information (PMDSI)
August 29,
2023		 Rivastigmine PDF PDF  
Finasteride PDF PDF
Appendix: Summary of Disproportionality Analysis Using VigiBase		  
Dabigatran etexilate methanesulfonate PDF PDF  
Peficitinib hydrobromide PDF PDF  
Cefazolin sodium PDF PDF  
Cefazolin sodium hydrate  
July 20,
2023		 Atorvastatin calcium hydrate PDF PDF
Appendix: Summary of Disproportionality Analysis Using VigiBase		 PMDSI No. 403
Ezetimibe/atorvastatin calcium hydrate
Ezetimibe/rosuvastatin calcium
Simvastatin
Pitavastatin calcium hydrate
Pitavastatin calcium hydrate/ezetimibe
Pravastatin sodium
Fluvastatin sodium
Rosuvastatin calcium
Amlodipine basilate/
atorvastatin calcium hydrate
Tirzepatide PDF PDF -
Minocycline hydrochloride
(oral dosage form)		 PDF PDF -
Minocycline hydrochloride (injections) -
Ensitrelvir fumaric acid PDF PDF -
June 13,
2023		 Ipilimumab (genetical recombination) PDF PDF -
Nivolumab (genetical recombination) PDF PMDSI No. 402
May 30,
2023		 Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) PDF - -
May 9,
2023		 Azilsartan PDF PDF PMDSI No. 401
Azilsartan
Azilsartan/amlodipine besilate
Alacepril
Aliskiren fumarate
Imidapril hydrochloride
Irbesartan
Irbesartan/amlodipine besilate
Irbesartan/trichlormethiazide
Enalapril maleate
Olmesartan medoxomil
Olmesartan medoxomil/
azelnidipine
Captopril
Candesartan cilexetil
Candesartan cilexetil/
amlodipine besilate
Candesartan cilexetil/
hydrochlorothiazide
Temocapril hydrochloride
Delapril hydrochloride
Telmisartan
Telmisartan/amlodipine besilate
Telmisartan/amlodipine besilate/hydrochlorothiazide
Telmisartan/hydrochlorothiazide
Trandolapril
Valsartan
Valsartan/amlodipine besilate
Valsartan/cilnidipine
Valsartan/hydrochlorothiazide
Benazepril hydrochloride
Perindopril erbumine
Lisinopril hydrate
Losartan potassium
Losartan potassium/
hydrochlorothiazide
Sacubitril valsartan sodium hydrate PDF
Mesalazine PDF PDF PMDSI No. 401
Mesalazine
Zinc acetate hydrate PDF PDF PMDSI No. 401
Zinc acetate hydrate
Leflunomide PDF PDF -
Ampicillin hydrate PDF PDF -
Ampicillin sodium -
Ampicillin hydrate/
cloxacillin sodium hydrate		 PDF -
Ampicillin sodium/
cloxacillin sodium hydrate		 -
Ioversol PDF PDF -

 

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Revisions of PRECAUTIONS (FY2023)
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