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Revisions of PRECAUTIONS (FY2021)

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 6,
2022
Aminolevulinic acid hydrochloride PDF PDF
Appendix 10 is not included.
See the Detailed information on revisions of PRECAUTIONS.
December 17,
2021
Blonanserin (oral dosage form) PDF PDF
Blonanserin (patches) PDF
Suvorexant PDF PDF
Fingolimod hydrochloride PDF PDF
Posaconazole PDF PDF
PDF
Posaconazole
Washed human red blood cell PDF PDF
Synthetic blood
Concentrated human blood platelet
Concentrated human blood platelet
Whole human blood PDF
Human red blood cells
Frozen-thawed human red blood cells PDF
December 8,
2021
Tacrolimus hydrate (ointment) PDF Re-examination Report
(only in Japanese)
December 3,
2021
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 73rd meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 23rd meeting) (joint meeting)
(only in Japanese)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(COVID-19 Vaccine Moderna Intramuscular Injection)
PDF
November 16,
2021
Atezolizumab (genetical recombination) PDF PDF
October 15,
2021
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 70th meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 19th meeting) (joint meeting)
(only in Japanese)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(COVID-19 Vaccine Moderna Intramuscular Injection)
PDF
October 12,
2021
Tofacitinib citrate PDF PDF
Cefoperazone sodium/sulbactam sodium PDF PDF
Ivermectin PDF PDF
September 21, 2021 Coronavirus modified uridine RNA vaccine (SARS-CoV-2)(Comirnaty intramuscular injection) PDF -
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)(COVID-19 Vaccine Moderna Intramuscular Injection) PDF -
COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) PDF -
September 7,
2021
Istradefylline PDF PDF
Lomitapide mesilate PDF
July 27,
2021
COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) PDF Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 64th meeting) and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 13th meeting)
(Only in Japanese)
July 20,
2021
Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) PDF
Magnesium sulfate hydrate (preparations indicated for eclampsia) PDF
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone sodium phosphate
PDF PDF
Magnesium sulfate hydrate/glucose (preparations indicated for inhibition of uterine contractions in threatened premature labour, and prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) PDF
Alendronate sodium hydrate
Alendronate sodium hydrate
Zoledronic acid hydrate
Pamidronate disodium hydrate
Minodronic acid hydrate
Sodium risedronate hydrate
PDF PDF
Ibandronate sodium hydrate
Ibandronate sodium hydrate
Etidronate disodium
PDF
Denosumab (genetical recombination) PDF
Romosozumab (genetical recombination) PDF
July 7,
2021
Coronavirus modified uridine RNA vaccine (SARS-CoV-2) PDF PDF
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
June 21,
2021
Nivolumab (genetical recombination) PDF PDF
June 15,
2021
Ixekizumab (genetical recombination) PDF PDF
Pembrolizumab (genetical recombination) PDF PDF
June 3,
2021
Clozapine PDF PDF
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS
June 2,
2021

June 1,
2021
(Originally Posted in Japanese)
Diclofenac etalhyaluronate sodium PDF Summary of Investigation
Blue Letter
Case report
May 13,
2021
Shosaikotokakikyosekko PDF PDF

 

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Revisions of PRECAUTIONS (FY2021)
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