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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)
November 27,
2018
Aluminum potassium sulfate hydrate/tannic acid (with saline) PDF PDF
Aluminum potassium sulfate hydrate/tannic acid (with analgesic agents) PDF
Calcitriol (injectable dosage form) PDF PDF
Freeze-dried live attenuated varicella vaccine PDF PDF
October 23,
 2018
Lamotrigine
Lamotrigine
PDF PDF
Secukinumab (genetical recombination) PDF PDF
Lenvatinib mesilate PDF PDF
October 16,
 2018
Atorvastatin calcium hydrate
Atorvastatin calcium hydrate
Ezetimibe/atorvastatin calcium hydrate
Pravastatin sodium
Pravastatin sodium
Pravastatin sodium
Amlodipine basilate/atorvastatin calcium hydrate
PDF PDF
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS
Clinofibrate PDF
Clofibrate PDF
Simvastatin
Simvastatin
PDF
Pitavastatin calcium hydrate
Pitavastatin calcium hydrate
PDF
Fenofibrate
Fenofibrate
Bezafibrate
Bezafibrate
PDF
Fluvastatin sodium PDF
Pemafibrate PDF
Rosuvastatin calcium
Rosuvastatin calcium
Rosuvastatin calcium
PDF
September 18,
 2018
Radium (223Ra) chloride PDF PDF
Sunitinib malate PDF PDF
Ampicillin hydrate
Ampicillin hydrate
Bacampicillin hydrochloride
Ampicillin sodium/cloxacillin sodium hydrate
Ampicillin sodium/cloxacillin sodium hydrate
PDF PDF
Ampicillin sodium PDF
Sultamicillin tosilate hydrate
Sultamicillin tosilate hydrate
PDF
Ampicillin hydrate/cloxacillin sodium hydrate PDF
Dolutegravir sodium PDF PDF
Dolutegravir sodium/abacavir sulfate/lamivudine PDF
August 21,
 2018
Amantadine hydrochloride
Amantadine hydrochloride
PDF Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in 2018 (Only in Japanese)
Oseltamivir phosphate
Oseltamivir phosphate
PDF
Zanamivir hydrate
Laninamivir octanoate hydrate
PDF
Baloxavir marboxil PDF
Favipiravir PDF
Peramivir hydrate PDF
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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