| 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 |
 |
|
Sultopride hydrochloride
Fluphenazine decanoate |
|
Sulpiride
Sulpiride
Sulpiride
Sulpiride |
|
| Nemonapride |
|
Haloperidol
Haloperidol
Haloperidol decanoate
Bromperidol
Mosapramine hydrochloride |
|
| Pimozide |
|
Blonanserin
Blonanserin
Perospirone hydrochloride hydrate |
|
| Aclatonium napadisilate |
|
| Pegfilgrastim (genetical recombination) |
|
Appendix:
A pharmacoepidemiological study on the association between G-CSF preparations and decreased platelet counts |
| Pembrolizumab (genetical recombination) |
|
|
Aciclovir (oral dosage forms)
Aciclovir (injectable dosage forms)
Valaciclovir hydrochloride |
|
|
| Amenamevir |
|
|
| Baloxavir marboxil |
|
|
February 25,
2020 |
Rotigotine |
|
|
| Allopurinol |
|
|
| Arsenic trioxide |
|
|
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 |
|
| Daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride |
|
| Fosravuconazole L-lysine ethanolate |
|
|
| Aminolevulinic acid hydrochloride |
|
|
January 21,
2020 |
Levodopa
Levodopa
Levodopa/carbidopa hydrate
Levodopa/benserazide hydrochloride |
|
|
| Levodopa/carbidopa hydrate/entacapone |
|
Olmesartan medoxomil
Olmesartan medoxomil/azelnidipine |
|
|
| Ipragliflozin L-Proline |
|
|
| Sitagliptin phosphate hydrate/ipragliflozin L-Proline |
|
| Secukinumab (genetical recombination) |
|
|
| Alemtuzumab (genetical recombination) |
|
|
December 3,
2019 |
Mecasermin (genetical recombination) |
|
|
| Atezolizumab (genetical recombination) |
|
|
| Osimertinib mesilate |
|
|
| Bilastine |
|
|
November 15,
2019 |
Apalutamide |
|
|
| Enzalutamide |
|
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 |
|
|
|
|
|
| D-Sorbitol (urologic irrigating solution) |
|
|
| Belimumab (genetical recombination) |
|
|
September 24,
2019 |
Baricitinib |
|
|
| Osimertinib mesilate |
|
|
| Ofloxacin (oral dosage form) |
|
|
| Garenoxacin mesilate hydrate |
|
| Sitafloxacin hydrate |
|
|
|
|
| Tosufloxacin tosilate hydrate (oral dosage form) |
|
| Norfloxacin (oral dosage form) |
|
| Pazufloxacin mesilate |
|
| Pipemidic acid hydrate |
|
| Prulifloxacin |
|
| Moxifloxacin hydrochloride (oral dosage form) |
|
|
|
|
| Lomefloxacin hydrochloride (oral dosage form) |
|
| Tocilizumab (genetical recombination) |
|
|
September 6,
2019 |
Romosozumab (genetical recombination) |
|
|
September 6,
2019 |
Trelagliptin succinate |
|
|
August 22,
2019 |
Apomorphine hydrochloride hydrate |
|
|
| Talipexole hydrochloride |
|
| Pramipexole hydrochloride hydrate |
|
| Pramipexole hydrochloride hydrate |
|
Bromocriptine mesilate
Pergolide mesilate |
|
| Rotigotine |
|
| Ropinirole hydrochloride |
|
| Cabergoline |
|
|
| Tofacitinib citrate |
|
|
| Freeze-dried BCG vaccine |
|
|
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 |
|
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese) |
| Phenylephrine hydrochloride |
|
| Ozagrel sodium |
|
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 |
|
|
| Topiroxostat |
|
July 9,
2019 |
Epoprostenol sodium |
|
|
| Nivolumab (genetical recombination) |
|
|
| Pembrolizumab (genetical recombination) |
|
| Palbociclib |
|
|
Cedar pollen extract powder
Dermatophagoides pteronyssinus extract/dermatophagoides farina extract |
|
|
Standardized cedar pollen extract (liquid, those for sublingual administration only)
Dermatophagoides pteronyssinus extract bulk powder/dermatophagoides farinae extract bulk powder |
|
Tramadol hydrochloride (oral dosage form)
Tramadol hydrochloride/acetaminophen |
|
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) |
|
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) |
|
June 18,
2019 |
Metformin Hydrochloride(preparations with a daily maximum dose of 2 250 mg) |
|
|
| Metformin Hydrochloride(preparations with a maximum daily dose of 750 mg) |
|
| Anagliptin/metformin hydrochloride |
|
| Alogliptin benzoate/metformin hydrochloride |
|
| Pioglitazone hydrochloride/metformin hydrochloride |
|
| Vildagliptin/metformin hydrochloride |
|
June 4,
2019 |
Eletriptan hydrobromide
Zolmitriptan
Naratriptan hydrochloride
Rizatriptan benzoate |
|
|
Sumatriptan
Sumatriptan succinate
Sumatriptan succinate |
|
| Sumatriptan succinate |
|
| Avelumab (genetical recombination) |
|
|
| Nivolumab (genetical recombination) |
|
|
| Pembrolizumab (genetical recombination) |
|
| Baloxavir marboxil |
|
|
May 20,
2019
May 17,
2019
(Originally Posted in Japanese) |
Abemaciclib |
|
|
May 9,
2019 |
Dulaglutide (genetical recombination) |
|
|
Ipragliflozin L-proline
Tofogliflozin hydrate |
|
|
| Empagliflozin |
|
| Empagliflozin/linagliptin |
|
| Canagliflozin hydrate |
|
| Sitagliptin phosphate hydrate/ipragliflozin L-proline |
|
| Dapagliflozin propylene glycolate hydrate |
|
| Teneligliptin hydrobromide hydrate/canagliflozin hydrate |
|
| Luseogliflozin hydrate |
|
| Nivolumab (genetical recombination) |
|
|
| Lenvatinib mesilate |
|
|
| Influenza HA vaccine |
|
|
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