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 31,
2020 |
Spiperone
Timiperone
Timiperone
Pipamperone hydrochloride |
 |
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Sultopride hydrochloride
Fluphenazine decanoate |
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Sulpiride
Sulpiride
Sulpiride
Sulpiride |
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Nemonapride |
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Haloperidol
Haloperidol
Haloperidol decanoate
Bromperidol
Mosapramine hydrochloride |
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Pimozide |
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Blonanserin
Blonanserin
Perospirone hydrochloride hydrate |
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Aclatonium napadisilate |
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Pegfilgrastim (genetical recombination) |
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Appendix:
A pharmacoepidemiological study on the association between G-CSF preparations and decreased platelet counts |
Pembrolizumab (genetical recombination) |
 |
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Aciclovir (oral dosage forms)
Aciclovir (injectable dosage forms)
Valaciclovir hydrochloride |
 |
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Amenamevir |
 |
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Baloxavir marboxil |
 |
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February 25,
2020 |
Rotigotine |
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Allopurinol |
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Arsenic trioxide |
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Asunaprevir
Glecaprevir hydrate/pibrentasvir
Sofosbuvir
Daclatasvir hydrochloride
Ledipasvir acetonate/sofosbuvir |
 |

Appendix:
A study on the effect of hepatitis C drugs on blood coagulability in patients on warfarin |
Elbasvir
Grazoprevir hydrate |
 |
Sofosbuvir/velpatasvir |
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Daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride |
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Fosravuconazole L-lysine ethanolate |
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Aminolevulinic acid hydrochloride |
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January 21,
2020 |
Levodopa
Levodopa
Levodopa/carbidopa hydrate
Levodopa/benserazide hydrochloride |
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Levodopa/carbidopa hydrate/entacapone |
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Olmesartan medoxomil
Olmesartan medoxomil/azelnidipine |
 |
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Ipragliflozin L-Proline |
 |
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Sitagliptin phosphate hydrate/ipragliflozin L-Proline |
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Secukinumab (genetical recombination) |
 |
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Alemtuzumab (genetical recombination) |
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December 3,
2019 |
Mecasermin (genetical recombination) |
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Atezolizumab (genetical recombination) |
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Osimertinib mesilate |
 |
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Bilastine |
 |
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November 15,
2019 |
Apalutamide |
 |
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Enzalutamide |
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November 12,
2019 |
Urokinase (60 000 units) |
 |
Material of the 9th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
October 29,
2019 |
Methylphenidate hydrochloride (sustained-release tablets) |
 |
Points for Consideration concerning the Use of Methylphenidate Hydrochloride Preparations (Concerta Tablets 18 mg, 27 mg, 36 mg)
Appendix: Outline of Logistic Management Implemented by Manufacturing Authorization Holders
(Both only in Japanese) |
October 29,
2019 |
Vonoprazan fumarate |
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|
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D-Sorbitol (urologic irrigating solution) |
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Belimumab (genetical recombination) |
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September 24,
2019 |
Baricitinib |
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Osimertinib mesilate |
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Ofloxacin (oral dosage form) |
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Garenoxacin mesilate hydrate |
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Sitafloxacin hydrate |
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|
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Tosufloxacin tosilate hydrate (oral dosage form) |
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Norfloxacin (oral dosage form) |
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Pazufloxacin mesilate |
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Pipemidic acid hydrate |
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Prulifloxacin |
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Moxifloxacin hydrochloride (oral dosage form) |
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|
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Lomefloxacin hydrochloride (oral dosage form) |
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Tocilizumab (genetical recombination) |
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September 6,
2019 |
Romosozumab (genetical recombination) |
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September 6,
2019 |
Trelagliptin succinate |
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August 22,
2019 |
Apomorphine hydrochloride hydrate |
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Talipexole hydrochloride |
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Pramipexole hydrochloride hydrate |
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Pramipexole hydrochloride hydrate |
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Bromocriptine mesilate
Pergolide mesilate |
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Rotigotine |
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Ropinirole hydrochloride |
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Cabergoline |
 |

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Tofacitinib citrate |
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Freeze-dried BCG vaccine |
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July 17,
2019 |
Suxamethonium chloride hydrate
Suxamethonium chloride hydrate |
 |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
Etilefrine hydrochloride |
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Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
Phenylephrine hydrochloride |
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Ozagrel sodium |
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Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
Purified tuberculin
Purified tuberculin |
 |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
July 9,
2019 |
Febuxostat |
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Topiroxostat |
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July 9,
2019 |
Epoprostenol sodium |
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Nivolumab (genetical recombination) |
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Pembrolizumab (genetical recombination) |
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Palbociclib |
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Cedar pollen extract powder
Dermatophagoides pteronyssinus extract/dermatophagoides farina extract |
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Standardized cedar pollen extract (liquid, those for sublingual administration only)
Dermatophagoides pteronyssinus extract bulk powder/dermatophagoides farinae extract bulk powder |
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Tramadol hydrochloride (oral dosage form)
Tramadol hydrochloride/acetaminophen |
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Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
Tramadol hydrochloride (injection) |
 |
Codeine phosphate hydrate (prescription drugs)
Codeine phosphate hydrate (prescription drugs)
Codeine phosphate hydrate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs) |
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Dihydrocodeine phosphate/platycodon fluidextract/glycyrrhiza extract/plantago herb extract/peony root extract (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/
diprophylline/dl-methylephedrine hydrochloride/
diphenhydramine salicylate/acetaminophen/bromovalerylurea (prescription drugs)
Dihydrocodeine phosphate/ephedrine hydrochloride/
ammonium chloride (prescription drugs) |
 |
Products containing codeine phosphate hydrate (OTC drugs)
Products containing dihydrocodeine phosphate (OTC drugs) |
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June 18,
2019 |
Metformin Hydrochloride(preparations with a daily maximum dose of 2 250 mg) |
 |
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Metformin Hydrochloride(preparations with a maximum daily dose of 750 mg) |
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Anagliptin/metformin hydrochloride |
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Alogliptin benzoate/metformin hydrochloride |
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Pioglitazone hydrochloride/metformin hydrochloride |
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Vildagliptin/metformin hydrochloride |
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June 4,
2019 |
Eletriptan hydrobromide
Zolmitriptan
Naratriptan hydrochloride
Rizatriptan benzoate |
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Sumatriptan
Sumatriptan succinate
Sumatriptan succinate |
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Sumatriptan succinate |
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Avelumab (genetical recombination) |
 |
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Nivolumab (genetical recombination) |
 |
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Pembrolizumab (genetical recombination) |
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Baloxavir marboxil |
 |
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May 20,
2019
May 17,
2019
(Originally Posted in Japanese) |
Abemaciclib |
 |
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May 9,
2019 |
Dulaglutide (genetical recombination) |
 |
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Ipragliflozin L-proline
Tofogliflozin hydrate |
 |
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Empagliflozin |
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Empagliflozin/linagliptin |
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Canagliflozin hydrate |
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Sitagliptin phosphate hydrate/ipragliflozin L-proline |
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Dapagliflozin propylene glycolate hydrate |
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Teneligliptin hydrobromide hydrate/canagliflozin hydrate |
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Luseogliflozin hydrate |
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Nivolumab (genetical recombination) |
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Lenvatinib mesilate |
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Influenza HA vaccine |
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