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Revisions of PRECAUTIONS (FY2020)

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)
July 20,
2020
Iodixanol
Iohexol (preparations with indications of cerebral angiography)
PDF PDF
Iopamidol
PDF
Iopromide PDF
Iohexol (preparations with indications of cerebral angiography, angiocardiography (including pulmonary artery angiography), aortography, and angiocardiography of pediatrics (including pulmonary artery angiography)) PDF
Ioversol PDF
Iomeprol PDF
June 25,
2020
Oxytocin PDF PDF(only in Japanese)
Dinoprost PDF
Dinoprostone (oral dosage form) PDF
Calonary L, Calonary M, Calonary H Infusion Solution
Hicaliq-1, Hicaliq-2, Hicaliq-3 Liquid
Hicaliq NC-L, Hicaliq NC-N, Hicaliq NC-H Infusion Solution
Rehabix-K1, Rehabix-K2 Infusion Solution
PDF PDF
The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
Amicaliq Infusion Solution
Paresafe Infusion Solution
Pareplus Infusion Solution
PDF
Amizet B Infusion Solution
Aminic Infusion Solution
Pleamin-P Injection, Hy-Pleamin Injection, Hy-Pleamin S Injection
Proteamin 12 Injection
Moriamin-S Injection
Moripron-F Infusion Solution
PDF
Amiparen Injection
Plas-amino Injection
PDF
Aminoleban Injection
Terufis Intravenous Drip Infusions
Hikarilevan Injection
PDF
Elneopa-NF No.1 Injection, Elneopa-NF No.2 Injection
Neoparen No.1 Injection, Neoparen No.2 Injection
Mixid L Injection, Mixid H Injection
PDF
Twinpal Infusion Solution
Bfluid Injection
PDF
Pntwin No.1, Pntwin No.2, Pntwin No.3 Infusion Solution
Fulcaliq 1, Fulcaliq 2, Fulcaliq 3 Infusion Solution
Onepal No.1, Onepal No.2 Infusion Solution
PDF
Morihepamin Intravenous Drip Infusions PDF
June 16,
2020
Memantine hydrochloride PDF PDF
Memantine hydrochloride
Bevacizumab (genetical recombination) PDF PDF
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 1]
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 2]
June 1,
2020
Selexipag PDF
PDF
The Appendix for draft revisions is not included. See the Detailed information on revisions of PRECAUTIONS.
Clopidogrel sulfate PDF
Clopidogrel sulfate/aspirin PDF
May 19,
2020
Insulin human (genetical recombination) PDF
PDF
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
Insulin aspart (genetical recombination) PDF
Insulin glulisine (genetical recombination) PDF
Insulin lispro (genetical recombination) PDF
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1]
Insulin human (genetical recombination) PDF PDF
Insulin human (genetical recombination)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
Insulin detemir (genetical recombination)
Insulin glulisine (genetical recombination)
Insulin degludec (genetical recombination)
Insulin glargine (genetical  recombination) [Insulin glargine biosimilar 1]
Insulin glargine (genetical  recombination) [Insulin glargine biosimilar 2]
Insulin degludec (genetical recombination)/insulin aspart (genetical recombination)
Insulin lispro (genetical recombination) PDF
Insulin lispro (genetical recombination)
Insulin lispro mix preparation 25
Insulin lispro mix preparation 50
Insulin degludec (genetical recombination)/liraglutide (genetical recombination)
Insulin glargine (genetical recombination)/lixisenatide
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1]
Apalutamide PDF PDF
Fulvestrant PDF PDF

 

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Revisions of PRECAUTIONS (FY2020)
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