| 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) |
March 27,
2018 |
Propofol
Propofol
Propofol
Propofol |
 |
|
Adrenaline (preparations indicated for
emergency supplemental treatment of
anaphylactic reactions caused by
allergens in vespid venom, food, drugs
and other allergens) |
|
|
Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions)
Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions) |
|
Asenapine maleate
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
olanzapine
olanzapine
olanzapine
olanzapine
quetiapine fumarate
quetiapine fumarate
quetiapine fumarate
clocapramine hydrochloride hydrate
clocapramine hydrochloride hydrate
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine
hydrochloride/promethazine
hydrochloride/phenobarbital
chlorpromazine phenolphthalinate
spiperone
zotepine
timiperone
timiperone
haloperidol
haloperidol
haloperidol
haloperidol
paliperidone
pipamperone
hydrochloride
fluphenazine decanoate
fluphenazine maleate
brexpiprazole
prochlorperazine mesilate
prochlorperazine maleate
propericiazine
bromperidol
perphenazine
perphenazine
hydrochloride
perphenazine fendizoate
perphenazine maleate
perospirone
hydrochloride hydrate
mosapramine hydrochloride
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
levomepromazine hydrochloride
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate |
|
Aripiprazole hydrate
Aripiprazole hydrate
Paliperidone palmitate
Haloperidol decanoate
Risperidone (injections) |
|
| Clozapine |
|
| Blonanserin |
|
March 27,
2018 |
Azithromycin hydrate (Tablets 250 mg/500 mg)
Azithromycin hydrate (Dry syrup)
Azithromycin hydrate (For pediatric use)
Azithromycin hydrate (For pediatric use)
Aztreonam
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin
Hydrate/potassium clavulanate
Amoxicillin
Hydrate/potassium clavulanate
Ampicillin Hydrate
Ampicillin Hydrate
Ampicillin Sodium
Ampicillin Sodium, Cloxacillin Sodium Hydrate (100mg preparation)
Imipenem Hydrate, Cilastatin Sodium
Imipenem Hydrate, Cilastatin Sodium
Erythromycin
Erythromycin Ethylsuccinate
Erythromycin Ethylsuccinate
Erythromycin Stearate
Ofloxacin (Tablets)
Kanamycin Monosulfate
Kanamycin Monosulfate
Kanamycin Sulfate
Clarithromycin
Clarithromycin
Clarithromycin
Clindamycin Hydrochloride
Clindamycin Phosphate (For injection)
Clindamycin Phosphate (For injection)
Chloramphenicol(For topical application)
Chloramphenicol(For oral use)
Chloramphenicol Sodium Succinate
Colistin Sodium Methanesulfonate
Colistin Sodium Methanesulfonate
Sitafloxacin Hydrate
Sitafloxacin Hydrate
Ciprofloxacin Hydrochloride Hydrate
Dibekacin Sulfate (For injection)
Dibekacin Sulfate (For injection)
Josamycin
Josamycin Propionate
Josamycin Propionate
Spiramycin Acetate
Sultamicillin Tosilate Hydrate
Sultamicillin Tosilate Hydrate
Sulfamethoxazole,Trimethoprim (For oral use)
Cefaclor
Cefaclor
Cefaclor
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalotin Sodium
Cefixime Hydrate
Cefepime Dihydrochloride Hydrate
Cefepime Dihydrochloride Hydrate
Cefozopran Hydrochloride
Cefotaxime Sodium
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hexetil Hydrochloride
Cefoperazone Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefditoren Pivoxil
Cefditoren Pivoxil
Cefdinir
Cefdinir
Cefdinir
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftizoxime Sodium
Ceftibuten Hydrate
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Cefpirome Sulfate
Cefpodoxime Proxetil
Cefpodoxime Proxetil
Cefminox Sodium Hydrate
Cefmetazole Sodium
Cefmetazole Sodium
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For ear and nose)
Cefroxadine Hydrate
Cefuroxime Axetil
Tetracycline Hydrochloride (For oral use)
Tetracycline Hydrochloride (For oral use)
Tebipenem Pivoxil
Demethylchlortetracycline Hydrochloride
Doxycycline Hydrochloride Hydrate
Tosufloxacin Tosilate Hydrate (Tablets)
Tosufloxacin Tosilate Hydrate (Tablets)
Tobramycin
Doripenem Hydrate
Nalidixic acid
Nalidixic acid
Norfloxacin (Tablets)
Norfloxacin (Tablets)
Bacampicillin Hydrochloride
Panipenem, Betamipron
Vancomycin Hydrochloride (Powder)
Pipemidic Acid Hydrate
Piperacillin Sodium
Piperacillin Sodium
Piperacillin Sodium
Faropenem Sodium Hydrate
Faropenem Sodium Hydrate
Prulifloxacin
Flomoxef Sodium
Benzylpenicillin Potassium
Benzylpenicillin Benzathine Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Sodium (For injection)
Fosfomycin Sodium (For injection)
Polymixin B Sulfate (Powder)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For injection)
Garenoxacin Mesilate Hydrate
Metronidazole (For oral use)
Metronidazole (For injection)
Meropenem Hydrate
Moxifloxacin hydrochloride (Tablets)
Latamoxef Sodium
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Roxithromycin
Lomefloxacin hydrochloride (For oral use) |
|
|
March 20,
2018 |
Tolvaptan |
|
|
| Selexipag |
|
|
Clopidogrel sulfate
Clopidogrel sulfate/aspirin |
|
| Anagliptin |
|
|
| Anagliptin |
|
Linagliptin
Teneligliptin hydrobromide hydrate
Teneligliptin hydrobromide hydrate/canagliflozin hydrate |
|
| Sterile talc |
|
|
February 13,
2018 |
Gardenia fruit
Gardenia fruit
Gardenia fruit
Gardenia fruit |
|
|
Inchinkoto extract
Inchinkoto extract
Inchinkoto extract
Orengedokuto extract
Orengedokuto extract
Orengedokuto extract
Orengedokuto extract
Kamishoyosan extract
Kamishoyosan extract
Kamishoyosan extract
Shiniseihaito extract
Shiniseihaito extract |
|
|
|
|
| Efavirenz |
|
|
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel, CT)
Iohexol (for urinary tract, blood vessel, CT) |
|
|
Iomeprol
Iomeprol |
|
|
Products containing gardenia fruit
(OTC drugs)
|
|
|
January 11,
2018 |
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole hydrate
Aripiprazole hydrate |
|
|
Teriparatide
(genetical recombination) |
|
|
Teriparatide acetate
Teriparatide acetate |
|
Edoxaban tosilate hydrate
Edoxaban tosilate hydrate |
|
|
Ipilimumab
(genetical recombination) |
|
|
| Lenvatinib mesilate |
|
|
November 28,
2017 |
Clozapine |
|
|
Gadoxetate sodium
Gadoteridol
Meglumine gadoterate
Gadobutrol |
|
|
Gadodiamide hydrate
Gadodiamide hydrate
Meglumine gadopentetate
Meglumine gadopentetate |
|
October 17,
2017 |
Levetiracetam
Levetiracetam
Levetiracetam |
|
|
Chlorhexidine hydrochloride/
diphenhydramine salicylate/
hydrocortisone acetate/
benzalkonium chloride concentrated solution 50 |
|
|
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate |
|
| Products containing chlorhexidine gluconate or products containing chlorhexidine hydrochloride (OTC drugs) |
|
|
| Linagliptin |
|
|
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Lansoprazole/amoxicillin hydrate/
clarithromycin
Lansoprazole/amoxicillin hydrate/
metronidazole
Rabeprazole sodium/amoxicillin hydrate/clarithromycin
Rabeprazole sodium/amoxicillin hydrate/metronidazole
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
Vonoprazan fumarate/amoxicillin hydrate/metronidazole |
|
|
Potassium clavulanate/
amoxicillin hydrate
Potassium clavulanate/
amoxicillin hydrate |
|
Moxifloxacin hydrochloride
(oral dosage form) |
|
|
September 12,
2017 |
Dabigatran etexilate methanesulfonate |
|
|
| Palivizumab (genetical recombination) |
|
|
| Interferon beta |
|
|
August 3,
2017 |
Riociguat |
|
|
Warfarin potassium
Warfarin potassium
Warfarin potassium |
|
|
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate |
|
|
| Azithromycin hydrate |
|
| Laninamivir octanoate hydrate |
|
|
July 4,
2017 |
Tramadol hydrochloride
Tramadol hydrochloride |
|
|
| Tramadol hydrochloride |
|
Tramadol hydrochloride/
acetaminophen |
|
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate |
|
Dihydrocodeine phosphate/diprophylline/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/bromovalerylurea |
|
Codeine phosphate hydrate/cherry bark extract
Dihydrocodeine phosphate/
platycodon fluidextract/
glycyrrhiza extract/
plantago herb extract/peony root extract |
|
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Dihydrocodeine phosphate
Dihydrocodeine phosphate
Dihydrocodeine phosphate |
|
Dihydrocodeine phosphate/
ephedrine hydrochloride/
ammonium chloride |
|
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 2 years old) |
|
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 12 years old and without the administration for patients younger than 2 years old) |
|
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations without the administration for patients younger than 12 years old) |
|
Loxoprofen sodium hydrate
(Cataplasms/Gel Patches)
Loxoprofen sodium hydrate(Tape)
Loxoprofen sodium hydrate(Gel)
Loxoprofen sodium hydrate(Spray) |
|
|
| Hydroxocobalamin |
|
|
Nivolumab
(genetical recombination) |
|
|
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fosfluconazole |
|
|
| Patch test products containing gold (I) sodium thiosulfate |
|
|
Loxoprofen sodium hydrate
(dermatologic preparation)
(guidance-mandatory drugs) |
|
|
May 30,
2017 |
Treprostinil |
|
|
Dulaglutide
(genetical recombination) |
|
|
| Bosutinib hydrate |
|
|
| Pneumococcal vaccine |
|
|
April 20,
2017 |
Denosumab
(genetical recombination)
(drug product with the indication for osteoporosis) |
|
|
Pembrolizumab
(genetical recombination) |
|
|
| Caspofungin acetate |
|
|
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