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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)
February 15, 2024 Topiramate PDF PDF  
Nintedanib ethanesulfonate PDF PDF
Appendix: Evaluation of the risk of artery dissection due to systemic exposure to VEGF/VEGFR inhibitors
 
Axitinib
Aflibercept beta (genetical recombination)
Cabozantinib malate
Sunitinib malate
Sorafenib tosilate
Pazopanib hydrochloride
Vandetanib
Ponatinib hydrochloride
Ramucirumab (genetical recombination)
Regorafenib hydrate
Lenvatinib mesilate
Linezolid PDF PDF  
Linezolid
Itraconazole PDF PDF  
February 8, 2024 Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Gobik Aqueous Suspension Syringes) PDF -  
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Quintovac Aqueous Suspension Injection) PDF -  
January 10, 2024 Sertraline hydrochloride PDF PDF
Appendix: Evaluation of the effect of antidepressants on indices of decreased platelet count using MID-NET®
 
 
Acetazolamide PDF PDF PMDSI No. 407
Acetazolamide sodium
Cortisone acetate PDF PDF PMDSI No. 407
Dexamethasone (oral dosage form) (preparations indicated for multiple myeloma) PDF
Dexamethasone (oral dosage form) (preparations indicated for lymphoid tumours) PDF
Dexamethasone sodium phosphate (injections)
Hydrocortisone
Hydrocortisone sodium succinate (preparations indicated for lymphoid tumours)
Prednisolone (oral dosage form)
Prednisolone sodium succinate
Methylprednisolone
Methylprednisolone sodium succinate
Methylprednisolone acetate
Dexamethasone palmitate PDF
Hydrocortisone sodium succinate (preparations not indicated for lymphoid tumours) PDF
Hydrocortisone sodium phosphate
Prednisolone sodium phosphate PDF
Atezolizumab (genetical recombination) PDF PDF PMDSI No. 407
Encorafenib PDF PDF PMDSI No. 407
Binimetinib
Pembrolizumab (genetical recombination) PDF PDF PMDSI No. 407
November 24, 2023 Nivolumab (genetical recombination) PDF -  
November 21, 2023 Metyrapone PDF PDF PMDSI No. 406
Apixaban PDF PDF PMDSI No. 406
Edoxaban tosilate hydrate
Dabigatran etexilate methanesulfonate
Rivaroxaban
Warfarin potassium PDF
Technetium (99mTc) galactosyl human serum albumin diethylenetriamine
pentaacetic acid
PDF PDF PMDSI No. 406
October 12, 2023 Acetaminophen (oral dosage form) PDF PDF
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. 
 
Acetaminophen (oral dosage form)  
Acetaminophen (injections) PDF  
Acetaminophen (suppository) PDF  
Tramadol hydrochloride/
acetaminophen
PDF  
Diprophylline/dihydrocodeine
phosphate/dl-methylephedrine
hydrochloride/diphenhydramine salicylate/acetaminophen/
bromovalerylurea
PDF  
October 12, 2023 Filgrastim (genetical recombination) PDF PDF -
Filgrastim (genetical recombination, biosimilar 1) -
Filgrastim (genetical recombination, biosimilar 2) -
Pegfilgrastim (genetical recombination) PDF -
Pegfilgrastim (genetical recombination, biosimilar 1) -
Lenograstim (genetical recombination) PDF -
Diazoxide PDF PDF -
Apalutamide PDF PDF PMDSI No. 405
Ipilimumab (genetical recombination) PDF PDF -
Technetium (99mTc) tetrofosmin PDF PDF PMDSI No. 405
COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) PDF PDF -
Adenosine PDF PDF -
August 29,
2023
Rivastigmine PDF PDF PMDSI No. 404
Finasteride PDF PDF
Appendix: Summary of Disproportionality Analysis Using VigiBase
-
Dabigatran etexilate methanesulfonate PDF PDF PMDSI No. 404
Peficitinib hydrobromide PDF PDF PMDSI No. 404
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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