| 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) |
Reference article in Pharmaceuticals and Medical Devices Safety Information (PMDSI) |
| 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) |
|
|
PMDSI No. 372 |
Aciclovir
(oral dosage forms)
Aciclovir
(injectable
dosage forms)
Valaciclovir hydrochloride |
|
|
- |
| Amenamevir |
|
|
- |
Baloxavir
marboxil |
|
|
- |
February
25,
2020 |
Rotigotine |
|
|
PMDSI No. 371 |
| 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 |
|
|
PMDSI No. 371 |
January
21,
2020 |
Levodopa
Levodopa
Levodopa/
carbidopa
hydrate
Levodopa/
benserazide hydrochloride |
|
|
- |
Levodopa/
carbidopa
hydrate/
entacapone |
|
- |
Olmesartan medoxomil
Olmesartan medoxomil/
azelnidipine |
|
|
PMDSI No. 370 |
| Ipragliflozin L-Proline |
|
|
PMDSI No. 370 |
Sitagliptin phosphate hydrate/
ipragliflozin L-Proline |
|
- |
Secukinumab
(genetical recombination) |
|
|
PMDSI No. 370 |
Alemtuzumab
(genetical recombination) |
|
|
- |
December
3,
2019 |
Mecasermin
(genetical recombination) |
|
|
- |
Atezolizumab
(genetical recombination) |
|
|
PMDSI No. 369 |
| Osimertinib mesilate |
|
|
PMDSI No. 369 |
| Bilastine |
|
|
PMDSI No. 369 |
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 |
|
|
PMDSI No. 368 |
Vonoprazan fumarate/
amoxicillin
hydrate/
clarithromycin
Vonoprazan fumarate/
amoxicillin
hydrate/
metronidazole |
|
- |
D-Sorbitol
(urologic
irrigating
solution) |
|
|
- |
Belimumab
(genetical recombination) |
|
|
- |
September
24,
2019 |
Baricitinib |
|
|
PMDSI No. 367 |
| Osimertinib mesilate |
|
|
PMDSI No. 367 |
Ofloxacin
(oral dosage
form) |
|
|
- |
| Garenoxacin mesilate hydrate |
|
- |
| Sitafloxacin hydrate |
|
- |
Ciprofloxacin
Ciprofloxacin
hydrochloride hydrate |
|
- |
Tosufloxacin tosilate hydrate
(oral dosage
form) |
|
- |
Norfloxacin
(oral dosage
form) |
|
- |
| Pazufloxacin mesilate |
|
- |
| Pipemidic acid hydrate |
|
- |
| Prulifloxacin |
|
- |
Moxifloxacin hydrochloride
(oral dosage
form) |
|
- |
Levofloxacin hydrate
(oral dosage
form)
Levofloxacin hydrate
(injectable 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 |
|
|
PMDSI No. 366 |
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) |
|
|
PMDSI No. 365 |
Pembrolizumab
(genetical recombination) |
|
- |
| Palbociclib |
|
|
PMDSI No. 365 |
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) |
|
|
PMDSI No. 364 |
| Pembrolizumab (genetical recombination) |
|
- |
Baloxavir
marboxil |
|
|
PMDSI No. 364 |
May
20,
2019
May
17,
2019
(Originally Posted in Japanese) |
Abemaciclib |
|
|
PMDSI No. 364 |
May
9,
2019 |
Dulaglutide
(genetical recombination) |
|
|
PMDSI No. 363 |
Ipragliflozin L-proline
Tofogliflozin hydrate |
|
|
- |
| Empagliflozin |
|
PMDSI No. 363 |
Empagliflozin/
linagliptin |
|
- |
| Canagliflozin hydrate |
|
- |
Sitagliptin phosphate hydrate/
ipragliflozin L-proline |
|
- |
| Dapagliflozin propylene glycolate hydrate |
|
- |
Teneligliptin hydrobromide hydrate/
canagliflozin hydrate |
|
- |
| Luseogliflozin hydrate |
|
- |
Nivolumab
(genetical recombination) |
|
|
PMDSI No. 363 |
| Lenvatinib mesilate |
|
|
PMDSI No. 363 |
| Influenza HA vaccine |
|
|
PMDSI No. 363 |
