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Revisions of PRECAUTIONS (FY2018)

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)
August 2,
 2018
Apremilast PDF PDF
Ceftriaxone sodium hydrate
Ceftriaxone sodium hydrate
Ceftriaxone sodium hydrate
PDF PDF
July 10,
 2018
Tacrolimus hydrate (ophthalmic solution) PDF PDF
Tacrolimus hydrate (ointment)
Tacrolimus hydrate (ointment)
PDF
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (injectable dosage form)
PDF
Azathioprine PDF PDF
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (injectable dosage form)
PDF PDF
June 5,
 2018
Amiodarone hydrochloride
Amiodarone hydrochloride
Amiodarone hydrochloride
PDF PDF
Filgrastim (genetical recombination)
Filgrastim (genetical recombination, follow-on biologic 1)
Filgrastim (genetical recombination, follow-on biologic 2)
Filgrastim (genetical recombination, follow-on biologic 3)
Pegfilgrastim (genetical recombination)
Lenograstim (genetical recombination)
PDF PDF
Everolimus (tablets 2.5mg/5mg)
Everolimus (dispersible tablets 2mg/3mg)
PDF PDF
Eftrenonacog alfa (genetical recombination) PDF PDF
Metronidazole (oral dosage form)
Metronidazole (injectable dosage form)
Lansoprazole/amoxicillin hydrate/metronidazole
Rabeprazole sodium/amoxicillin hydrate/metronidazole
Vonoprazan fumarate/amoxicillin hydrate/metronidazole
PDF PDF
April 19,
 2018
Omarigliptin
Saxagliptin hydrate
Trelagliptin succinate
PDF PDF
Cladribine PDF PDF
Pembrolizumab (genetical recombination) PDF PDF
Tosufloxacin tosilate hydrate (for oral use)
Tosufloxacin tosilate hydrate (for oral use)
Tosufloxacin tosilate hydrate (for oral use)
PDF PDF

 

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Revisions of PRECAUTIONS (FY2018)
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