| 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 21,
2017 |
Lamotrigine |
 |
|
Aluminum Potassium Sulfate Hydrate, Tannic Acid
Aluminum Potassium Sulfate Hydrate, Tannic Acid |
|
|
| Amobarbital |
|
(Attachment 3 has been omitted in this report.
Please see the corresponding section of Detailed information on revisions of PRECAUTIONS.) |
Alprazolam
Ethyl Loflazepate
(Fine Granules)
Ethyl Loflazepate (Tablets) |
|
| Eszopiclone |
|
Estazolam (Tablets)
Estazolam (Powder) |
|
Oxazolam (Tablets ・ Powder)
Oxazolam (Fine Granules) |
|
| Quazepam |
|
| Cloxazolam |
|
| Clorazepate Dipotassium |
|
Chlordiazepoxide (Tablets)
Chlordiazepoxide (Powder)
Diazepam (Powder)
Diazepam (Tablets)
Diazepam (Syrup)
Diazepam (Injection)
Diazepam (Injection) |
|
| Secobarbital Sodium |
|
| Zopiclone |
|
Zolpidem Tartrate (Tablets)
Zolpidem Tartrate (Tablets)
Zolpidem Tartrate
(Oral Solution) |
|
| Triazolam (Tablets) |
|
Triclofos Sodium
Bromovalerylurea |
|
Nitrazepam (Powder)
Nitrazepam (Fine Granules)
Nitrazepam (Tablets) |
|
| Nimetazepam |
|
Haloxazolam
Clotiazepam (Granules)
Clotiazepam (Tablets) |
|
Phenobarbital
(Oral dosage form)
Phenobarbital Sodium (Suppository)
Phenobarbital Sodium (Suppository) |
|
Phenobarbital (Injection)
Phenytoin/Phenobarbital
Phenytoin/Phenobarbital/
Caffeine and Sodium Benzoate
Phenobarbital Sodium (Injection) |
|
| Fludiazepam |
|
| Flutazolam |
|
| Flutoprazepam |
|
Flunitrazepam (Tablets)
Bromazepam
(Tablets ・ Fine Granules) |
|
| Flurazepam Hydrochloride |
|
Brotizolam (Tablets)
Brotizolam (Tablets) |
|
| Pentobarbital Calcium |
|
Chloral Hydrate (Suppository)
Chloral Hydrate (Enemas) |
|
| Mexazolam |
|
| Medazepam |
|
| Rilmazafone Hydrochloride Hydrate |
|
Lorazepam
Lormetazepam |
|
| Clonazepam |
|
| Clobazam |
|
| Diazepam (Suppository) |
|
| Primidone |
|
| Midazolam (products with an indication to treat status epilepticus) |
|
Etizolam (Fine Granules)
Etizolam (Tablets)
Etizolam (Tablets) |
|
February 14,
2017 |
Hydroxyzine Hydrochloride (Injection)
Hydroxyzine Hydrochloride (Tablets)
Hydroxyzine Pamoate (Powders)
Hydroxyzine Pamoate (Capsules/Dry Syrup)
Hydroxyzine Pamoate (Syrup)
Hydroxyzine Pamoate (Tablets) |
|
|
| Vemurafenib |
|
|
January 10,
2017 |
Iguratimod |
|
|
| Lenalidomide hydrate |
|
|
Interferon beta-1b
(genetical recombination) |
|
|
November 25,
2016 |
Duloxetine hydrochloride
Venlafaxine hydrochloride
Milnacipran hydrochloride |
|
|
November 22,
2016 |
Polaprezinc (Granules)
Polaprezinc (Tablets) |
|
|
| Formalin |
|
|
Formalin/Cresol
Cresol/Formalin/Clove oil/
Zinc oxide mixt
Formalin/Guaiacol |
|
Allopurinol
Allopurinol
Allopurinol |
|
|
Alogliptin benzoate
Alogliptin benzoate/
Pioglitazone hydrochloride
Linagliptin
Teneligliptin hydrobromide hydrate
Alogliptin benzoate/
Metformin hydrochloride |
|
|
Zoledronic acid hydrate
Zoledronic acid hydrate
Zoledronic acid hydrate
Zoledronic acid hydrate |
|
|
| Famciclovir |
|
|
October 18,
2016 |
Atorvastatin calcium hydrate
Atorvastatin calcium hydrate
Simvastatin
Simvastatin
Pitavastatin calcium hydrate
Pitavastatin calcium hydrate
Pravastatin sodium
Fluvastatin sodium
Rosuvastatin calcium |
|
|
Amlodipine besilate/
Atorvastatin calcium hydrate |
|
Warfarin potassium (Tablets)
Warfarin potassium (Granules)
Warfarin potassium (Fine Granules) |
|
|
Miconazole (Oral Gel)
Miconazole (Injection) |
|
Voriconazole (Tablets)
Voriconazole (Dry Syrup)
Voriconazole (Injection)
Itraconazole (Capsules)
Itraconazole (Tablets)
Itraconazole (Oral Solution)
Itraconazole (Injection)
Fluconazole (Capsules)
Fluconazole (Dry Syrup)
Fluconazole (Injections)
Fluconazole (Injections)
Fluconazole (Injections)
Fosfluconazole |
|
| Ustekinumab (genetical recombination) |
|
|
| Nivolumab (genetical recombination) |
|
|
| Daptomycin |
|
|
| Peramivir hydrate |
|
|
September 13,
2016 |
Natalizumab (genetical recombination) |
|
|
Nartograstim (genetical recombination)
Filgrastim (genetical recombination)(including follow-on biologics/biosimilars)
Filgrastim (genetical recombination)[filgrastim biosimilar 1]
Filgrastim (genetical recombination)[filgrastim biosimilar 2]
Filgrastim (genetical recombination)[filgrastim biosimilar 3]
Lenograstim (genetical recombination) |
|
|
| Pegfilgrastim (genetical recombination) |
|
| Eltrombopag olamine |
|
|
| Afatinib maleate |
|
|
| Corticorelin(human) |
|
|
August 4,
2016 |
Olanzapine (Tablets)
Olanzapine (Tablets)
Olanzapine (Fine granules)
Olanzapine (Injection) |
|
|
| Azosemide |
|
|
Imatinib mesilate
Imatinib mesilate
Dasatinib hydrate |
|
|
| Nilotinib hydrochloride hydrate |
|
| Bosutinib hydrate |
|
| Sitafloxacin hydrate |
|
|
July 5,
2016 |
Diclofenac sodium (Oral tablets)
Diclofenac sodium (Suppositories)
Diclofenac sodium (Capsules)
Diclofenac sodium (Enema ointment) |
|
|
| Oxytocin |
|
|
| Benzoyl peroxide |
|
|
| Clindamycin phosphate hydrate / Benzoyl peroxide |
|
|
| Apixaban |
|
|
| Nintedanib ethanesulfonate |
|
|
| Fingolimod hydrochloride |
|
|
| Carmustine |
|
|
| Ombitasvir hydrate / Paritaprevir hydrate / Ritonavir |
|
|
| Sofosbuvir |
|
|
| Ribavirin |
|
| Ledipasvir acetonate / Sofosbuvir |
|
May 31,
2016 |
Levetiracetam (Tablets)
Levetiracetam (Dry Syrup)
Levetiracetam (Injection) |
|
|
Alendronate Sodium Hydrate (Tablets)
Alendronate Sodium Hydrate (Tablets)
Alendronate Sodium Hydrate (Oral Jelly)
Alendronate Sodium Hydrate (Injection)
Alendronate Sodium Hydrate (Injection)
Ibandronate Sodium Hydrate (Tablets)
Ibandronate Sodium Hydrate (Injection)
Etidronate Disodium
Zoledronic Acid Hydrate
Zoledronic Acid Hydrate
Pamidronate Disodium Hydrate
Minodronic Acid Hydrate
Minodronic Acid Hydrate
Risedronate Sodium Hydrate
Risedronate Sodium Hydrate
Risedronate Sodium Hydrate |
|
|
May 18,
2016 |
Asunaprevir
Simeprevir Sodium
Telaprevir
Vaniprevir |
|
|
|
|
|
April 21,
2016 |
Gabapentin (Tablets)
Gabapentin (Syrup) |
|
|
Levodopa (Tablets)
Levodopa (Capsules, Powders)
Levodopa (Injections)
Levodopa/Benserazide hydrochloride combination product
Levodopa/Carbidopa hydrate combination product
Levodopa/Carbidopa hydrate/Entacapone combination product |
|
|
| Gabapentin enacarbil |
|
|
| Edoxaban tosilate hydrate |
|
|
Rivaroxaban (Tablets)
Rivaroxaban (Fine Granules) |
|
|
Sitagliptin phosphate hydrate
Vildagliptin
Vildagliptin/Metformin hydrochloride combination product |
|
|
| Afatinib maleate |
|
|
| Trabectedin |
|
|
| Fexofenadine hydrochloride/Pseudoephedrine hydrochloride combination product |
|
|
Oseltamivir phosphate (Capsules)
Oseltamivir phosphate (Dry Syrup) |
|
|
| Peramivir hydrate |
|
|
| Sodium chloride/Potassium chloride/Sodium sulfate anhydrous/Macrogol 4000/Ascorbic acid/Sodium L-ascorbate combination product |
|
|
Products containing pseudoephedrine hydrochloride (OTC drugs)
Products containing pseudoephedrine sulfate (OTC drugs) |
|
|
