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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)
October 6,
2020
Vonoprazan fumarate PDF PDF
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
Vonoprazan fumarate/amoxicillin hydrate/metronidazole
PDF
Cytarabine (excluding 400 mg and 1 g preparations) PDF PDF
Tazobactam/piperacillin hydrate PDF PDF
September 8,
2020
Ofloxacin (preparations for otic use) PDF PDF
Chloramphenicol (preparations for otic use)
Fosfomycin sodium (preparations for otic use)
Gentamicin sulfate (injections)
PDF
Cefmenoxime hydrochloride (preparations for otic and nasal use)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Tetracycline hydrochloride (powders, capsules)
Tetracycline hydrochloride (powders, capsules)
Polymixin B sulfate (powders)
Clindamycin hydrochloride
Clindamycin phosphate (injections)
Benzylpenicillin potassium
Benzylpenicillin benzathine hydrate
Lincomycin hydrochloride hydrate
Lincomycin hydrochloride hydrate
Aztreonam
Amoxicillin hydrate
Ampicillin hydrate
Ampicillin sodium
Potassium clavulanate/amoxicillin hydrate
Dibekacin sulfate (injections)
Sultamicillin tosilate hydrate
Cefaclor
Cefazolin sodium
Cefazolin sodium hydrate
Cefalexin (oral dosage form with indications for otitis media)
Cephalothin sodium
Cefixime hydrate
Cefixime hydrate
Cefepime dihydrochloride hydrate
Cefozopran hydrochloride
Cefotiam hydrochloride (intravenous injections)
Cefcapene pivoxil hydrochloride hydrate
Cefditoren pivoxil
Cefdinir
Ceftazidime hydrate
Cefteram pivoxil
Ceftriaxone sodium hydrate
Cefpodoxime proxetil
Cefroxadine hydrate
Cefuroxime axetil
Tebipenem pivoxil
Doripenem hydrate
Bacampicillin hydrochloride
Panipenem/betamipron
Faropenem sodium hydrate
Flomoxef sodium
Fosfomycin calcium hydrate
Meropenem hydrate
Chloramphenicol sodium succinate
Demethylchlortetracycline hydrochloride
Doxycycline hydrochloride hydrate
Minocycline hydrochloride (oral dosage form)
Kanamycin sulfate
PDF
Lomefloxacin hydrochloride (preparations for otic use)
Lomefloxacin hydrochloride (preparations for otic use)
PDF
Azithromycin Hydrate (oral dosage form for pediatric use)
Erythromycin
Clarithromycin
Spiramycin acetate
Roxithromycin
Tosufloxacin tosilate hydrate (oral dosage form without dosage and administration for pediatric use)
Norfloxacin (oral dosage form with indications for otitis media)
PDF
Erythromycin ethylsuccinate
Erythromycin stearate
Josamycin
Josamycin propionate
PDF
Tosufloxacin tosilate hydrate (oral dosage form for pediatric use) PDF
September 8,
2020
Relugolix PDF PDF
Hydroxychloroquine sulfate PDF PDF
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
Memantine hydrochloride
PDF PDF
Bevacizumab (genetical recombination)
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 1]
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 2]
PDF PDF
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)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
PDF
PDF
Insulin aspart (genetical recombination) PDF
Insulin glulisine (genetical recombination) PDF
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1]
PDF
Insulin human (genetical recombination)
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)
PDF PDF
Insulin lispro (genetical recombination)
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]
PDF
Apalutamide PDF PDF
Fulvestrant PDF PDF

 

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Revisions of PRECAUTIONS (FY2020)
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