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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)
Reference article (Important Safety Information) in Pharmaceuticals and Medical Devices Safety Information (PMDSI)
March 27, 2023 Anti-human thymocyte immunoglobulin, rabbit PDF - -
March 23, 2023 Borofalan (10B) PDF PDF PMDSI 400
Enviomycin sulfate PDF PDF -
Cycloserine -
Aluminoparaaminosalicylate calcium hydrate -
Isoniazid -
Isoniazid -
Isoniazid sodium methanesulfonate hydrate -
Ethionamide -
Calcium paraaminosalicylate hydrate -
Pyrazinamide -
Bedaquiline fumarate -
Kanamycin sulfate PDF -
Streptomycin sulfate -
Rifabutin PDF -
Rifampicin PDF -
Ethambutol hydrochloride -
Levofloxacin hydrate (oral dosage form) -
Delamanid PDF -
February 14, 2023 Exenatide PDF PDF PMDSI 399
Semaglutide (genetical recombination)
Semaglutide (genetical recombination)
Dulaglutide (genetical recombination)
Lixisenatide
Liraglutide (genetical recombination)
Insulin glargine (genetical recombination)/lixisenatide
Insulin degludec (genetical recombination)/liraglutide (genetical recombination)
Tirzepatide PDF
Tazobactam/piperacillin hydrate PDF PDF PMDSI 399
January 17, 2023

*February 10, 2023
Administrative Notice of Partial CorrectionPDF
Acetaminophen
(oral dosage form)
PDF PDF PMDSI 398
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 PMDSI 398
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 PMDSI 398
Preparations containing acetaminophen (oral dosage form) (OTC drugs) PDF
(corrected version)
PDF PMDSI 398
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 PMDSI 397
Candesartan cilexetil/
hydrochlorothiazide
PDF
Valsartan/
hydrochlorothiazide
Losartan potassium/
hydrochlorothiazide
PDF
Roxadustat PDF PDF PMDSI 397
Imatinib mesilate PDF PDF PMDSI 397
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 PMDSI 396
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 PMDSI 395
July 20, 2022 Eszopiclone PDF PDF -
Zopiclone PDF -
Zolpidem tartrate PDF -
Triazolam PDF PDF
-
PDF -
Avelumab (genetical recombination) PDF PDF PMDSI 394
Durvalumab (genetical recombination) PMDSI 394
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 PMDSI 393
Nivolumab (genetical recombination) PDF PDF -
Pembrolizumab (genetical recombination) -
Vonoprazan fumarate/amoxicillin hydrate/metronidazole PDF PDF -
Rabeprazole sodium/amoxicillin hydrate/metronidazole -
Nirmatrelvir/ritonavir PDF PDF PMDSI 393
Molnupiravir PDF PDF PMDSI 393
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 PMDSI 392
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.
-
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PDF
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Revisions of PRECAUTIONS (FY2022)
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