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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)
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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