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Revisions of PRECAUTIONS (FY2022)

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)
January 17, 2023 Acetaminophen (oral dosage form) PDF PDF
Acetaminophen (oral dosage form)
Acetaminophen (suppositories)
Tramadol hydrochloride/acetaminophen
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Diprophylline/ dihydrocodeine phosphate/dl-methylephedrine hydrochloride/diphenhydramine salicylate/acetaminophen/ bromovalerylurea
Acetaminophen (injections) PDF
Pyrazolone-based antipyretics, analgesics and anti-inflammatory combination drug
Clopidogrel sulfate PDF PDF
Clopidogrel sulfate/aspirin
Alendronate sodium hydrate PDF PDF
Appendix: Database study using MID-NET® on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations
Alendronate sodium hydrate
Ibandronate sodium hydrate PDF
Ibandronate sodium hydrate
Etidronate disodium PDF
Zoledronic acid hydrate (preparations indicated for osteoporosis) PDF
Minodronic acid hydrate PDF
Sodium risedronate hydrate PDF
Hydroxychloroquine sulfate PDF PDF
Imatinib mesilate PDF PDF
Oral live attenuated human rotavirus vaccine PDF PDF
Preparations containing acetaminophen (oral dosage form) (OTC drugs) PDF PDF
Acetaminophen (suppositories) (OTC drugs)
January 12, 2023 Hydroxyethylated starch 70000 PDF PDF
Appendix 7 is not included. See the Detailed information on revisions of PRECAUTIONS.
Hydroxyethylated starch 70000/sodium chloride/potassium chloride/calcium chloride hydrate/sodium lactate
Hydroxyethylated starch 130000 PDF
December 5, 2022 Amlodipine besilate PDF PDF
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS.
Nifedipine PDF PDF
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS.
November 16, 2022 Hydrochlorothiazide PDF PDF
Candesartan cilexetil/hydrochlorothiazide PDF
Valsartan/hydrochlorothiazide
Losartan potassium/hydrochlorothiazide PDF
Roxadustat PDF PDF
Imatinib mesilate PDF PDF
Amoxicillin hydrate PDF PDF
Potassium clavulanate/amoxicillin hydrate PDF
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin PDF
Vonoprazan fumarate/amoxicillin hydrate/metronidazole
Rabeprazole sodium/amoxicillin hydrate/clarithromycin PDF
Rabeprazole sodium/amoxicillin hydrate/metronidazole PDF
October 20, 2022 Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.1), Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5))
PDF -
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intramuscular Injection (Bivalent: Original/Omicron BA.1))
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection (Monovalent: Original))
PDF -
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intramuscular Injection (Monovalent: Original))
PDF -
October 12, 2022 Pemafibrate PDF PDF
(References) Material for the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 13th meeting) (Only in Japanese)
October 12, 2022 Loxoprofen sodium hydrate (oral dosage form) (prescription drug) PDF PDF
Methotrexate PDF PDF
Methotrexate
Methotrexate
Methotrexate
Ipilimumab (genetical recombination) PDF PDF
Nivolumab (genetical recombination) PDF
Pembrolizumab (genetical recombination) PDF
Itraconazole (tablets, capsules) PDF PDF
Itraconazole (oral solution) PDF
Itraconazole (injections) PDF
Preparations containing loxoprofen sodium hydrate (oral dosage form) (OTC drugs) PDF PDF
September 13, 2022 Riociguat PDF PDF
Atazanavir sulfate PDF
Ritonavir PDF
Lopinavir/ritonavir PDF
August 30, 2022 Hydroxychloroquine sulfate PDF PDF
Ramucirumab (genetical recombination) PDF PDF
July 20, 2022 Eszopiclone PDF PDF
Zopiclone PDF
Zolpidem tartrate PDF
Triazolam PDF
PDF
PDF
Avelumab (genetical recombination) PDF PDF
Durvalumab (genetical recombination)
Bortezomib PDF PDF
Posaconazole
Posaconazole
PDF PDF
Iopamidol PDF PDF
Iohexol
Iomeprol PDF
July 8,
2022
Recombinant COVID-19 (SARS-CoV-2) vaccine
(Nuvaxovid Intramuscular Injection)
PDF Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 81st meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 6th meeting) (joint meeting) (Only in Japanese)
June 14, 2022 Cetuximab sarotalocan sodium (genetical recombination) PDF PDF
Nivolumab (genetical recombination) PDF PDF
Pembrolizumab (genetical recombination)
Vonoprazan fumarate/amoxicillin hydrate/metronidazole PDF PDF
Rabeprazole sodium/amoxicillin hydrate/metronidazole
Nirmatrelvir/ritonavir PDF PDF
Molnupiravir PDF PDF
Metronidazole (oral dosage form) PDF PDF
Metronidazole (injections) PDF
June 10, 2022 Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection)
PDF Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 80th meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 5th meeting) (joint meeting) (Only in Japanese)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection for 5 to 11 years old)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection))
May 13,
2022
Dexamethasone (oral dosage form) (preparations indicated for pituitary suppression tests) PDF PDF
Dexamethasone (oral dosage form) (preparations not indicated for pituitary suppression tests) PDF
Dexamethasone palmitate
Dexamethasone sodium phosphate (injections) PDF
Betamethasone (oral dosage form) PDF
Betamethasone (suppositories) PDF
Betamethasone acetate/betamethasone sodium phosphate
Betamethasone sodium phosphate (enemas)
Betamethasone/d-chlorpheniramine maleate PDF
Betamethasone sodium phosphate (injections)
Teicoplanin PDF PDF
April 26,
2022
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection)
PDF -
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection))
PDF -
April 4,
2022
Interferon beta-1a (genetical recombination) PDF PDF
Appendix 5 and 6 are not included.
See the Detailed information on revisions of PRECAUTIONS.
Interferon beta-1b (genetical recombination) PDF
April 4,
2022
Somatropin (genetical recombination) PDF PDF
Appendix 5 is not included.
See the Detailed information on revisions of PRECAUTIONS.
PDF
PDF
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Revisions of PRECAUTIONS (FY2022)
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