| 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 30,
2021 |
Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) |
 |
|
- |
| Magnesium sulfate hydrate (preparations indicated for eclampsia) |
|
- |
| Ritodrine hydrochloride (oral dosage form) |
|
- |
| Ritodrine hydrochloride (injections) |
|
PMDSI No. 382 |
| Magnesium sulfate hydrate/glucose (preparations indicated for inhibition of uterine contractions in threatened premature labour, and prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) |
|
- |
| Cetuximab (genetical recombination) |
|
|
- |
| Durvalumab (genetical recombination) |
|
|
PMDSI No. 382 |
| Iopamidol |
|
|
- |
February 25,
2021
*March 30, 2021
Administrative Notice of Partial Correction |
Aspirin |
|
|
- |
Aspirin
Aspirin/dialuminate |
|
- |
Ampiroxicam
Piroxicam |
|
- |
| Isopropylantipyrine |
|
- |
Pyrazolone-based antipyretics, analgesics and anti-inflammatory combination drug
Ethenzamide |
|
- |
Ibuprofen
Celecoxib
Naproxen
Pranoprofen (oral agents)
Flurbiprofen axetil
Loxoprofen sodium hydrate
Lornoxicam |
|
- |
Etodolac
Nabumetone
Flurbiprofen
Mefenamic acid
Mefenamic acid
Esflurbiprofen/mentha oil |
|
- |
| Ketoprofen |
|
- |
| Ketoprofen |
|
- |
| Zaltoprofen |
|
- |
Sodium salicylate/dibucaine combination drug
Sodium salicylate/dibucaine combination drug
Bucolome
Flufenamate aluminum
Mofezolac |
|
- |
| Sulpyrine hydrate |
|
- |
| Tiaprofenic acid |
|
- |
| Migrenin |
|
- |
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine
Non-pyrine common cold medicine |
(corrected version) |
- |
Ibuprofen piconol
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Methyl salicylate/diphenhydramine combination drug
Methyl salicylate/glycyrrhetinic acid combination stick
Suprofen |
|
- |
Indometacin (agents for epidermis)
Ketoprofen
Diclofenac sodium (agents for epidermis)
Piroxicam
Felbinac
Flurbiprofen
Loxoprofen sodium hydrate
Salicylic acid
Salicylic acid
Salicylic acid adhesive plaster |
|
- |
| Methyl salicylate |
|
- |
| Adrenal extract and heparinoid combination drug |
|
- |
Aspirin
Aspirin/dialuminate
Aspirin/lansoprazole
Clopidogrel sulfate/aspirin |
|
- |
| Aspirin/vonoprazan fumarate |
|
- |
Salbutamol sulfate
Salbutamol sulfate |
|
|
PMDSI No. 381 |
January 26,
2021 |
Amiodarone hydrochloride (oral dosage form) |
|
Appendix 4-1 and 4-2 are not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
| Sildenafil citrate (preparations indicated for pulmonary arterial hypertension) |
|
- |
January 26,
2021 |
Alemtuzumab (genetical recombination) |
|
|
- |
| Pomalidomide |
|
|
PMDSI No. 380 |
December 21,
2020 |
Lidocaine hydrochloride/adrenaline (excluding preparations for dental use) |
|
|
- |
| Adrenaline (preparations indicated for prolonged action of local anaesthetics and for prevention and treatment of local haemorrhage during surgery) |
|
- |
December 8,
2020 |
Clopidogrel sulfate |
|
|
- |
| Prasugrel hydrochloride |
|
- |
| Venetoclax |
|
|
- |
Posaconazole
Posaconazole |
|
- |
| Eculizumab (genetical recombination) |
|
|
- |
November 5,
2020 |
Glatiramer acetate |
|
|
- |
Nivolumab (genetical recombination)
Nivolumab (genetical recombination) |
|
|
PMDSI No. 378 |
October 6,
2020 |
Vonoprazan fumarate |
|
|
PMDSI No. 377 |
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
Vonoprazan fumarate/amoxicillin hydrate/metronidazole |
|
- |
| Cytarabine (excluding 400 mg and 1 g preparations) |
|
|
- |
| Tazobactam/piperacillin hydrate |
|
|
- |
September 8,
2020 |
Ofloxacin (preparations for otic use) |
|
|
- |
Chloramphenicol (preparations for otic use)
Fosfomycin sodium (preparations for otic use)
Gentamicin sulfate (injections) |
|
- |
Cefmenoxime hydrochloride (preparations for otic and nasal use)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Tetracycline hydrochloride (powders, capsules)
Tetracycline hydrochloride (powders, capsules)
Polymixin B sulfate (powders)
Clindamycin hydrochloride
Clindamycin phosphate (injections)
Benzylpenicillin potassium
Benzylpenicillin benzathine hydrate
Lincomycin hydrochloride hydrate
Lincomycin hydrochloride hydrate
Aztreonam
Amoxicillin hydrate
Ampicillin hydrate
Ampicillin sodium
Potassium clavulanate/amoxicillin hydrate
Dibekacin sulfate (injections)
Sultamicillin tosilate hydrate
Cefaclor
Cefazolin sodium
Cefazolin sodium hydrate
Cefalexin (oral dosage form with indications for otitis media)
Cephalothin sodium
Cefixime hydrate
Cefixime hydrate
Cefepime dihydrochloride hydrate
Cefozopran hydrochloride
Cefotiam hydrochloride (intravenous injections)
Cefcapene pivoxil hydrochloride hydrate
Cefditoren pivoxil
Cefdinir
Ceftazidime hydrate
Cefteram pivoxil
Ceftriaxone sodium hydrate
Cefpodoxime proxetil
Cefroxadine hydrate
Cefuroxime axetil
Tebipenem pivoxil
Doripenem hydrate
Bacampicillin hydrochloride
Panipenem/betamipron
Faropenem sodium hydrate
Flomoxef sodium
Fosfomycin calcium hydrate
Meropenem hydrate
Chloramphenicol sodium succinate
Demethylchlortetracycline hydrochloride
Doxycycline hydrochloride hydrate
Minocycline hydrochloride (oral dosage form)
Kanamycin sulfate |
|
- |
Lomefloxacin hydrochloride (preparations for otic use)
Lomefloxacin hydrochloride (preparations for otic use) |
|
- |
Azithromycin Hydrate (oral dosage form for pediatric use)
Erythromycin
Clarithromycin
Spiramycin acetate
Roxithromycin
Tosufloxacin tosilate hydrate (oral dosage form without dosage and administration for pediatric use)
Norfloxacin (oral dosage form with indications for otitis media) |
|
- |
Erythromycin ethylsuccinate
Erythromycin stearate
Josamycin
Josamycin propionate |
|
- |
| Tosufloxacin tosilate hydrate (oral dosage form for pediatric use) |
|
- |
September 8,
2020 |
Relugolix |
|
|
PMDSI No. 376 |
| Hydroxychloroquine sulfate |
|
|
- |
July 20,
2020 |
Iodixanol
Iohexol (preparations with indications of cerebral angiography) |
|
|
- |
| Iopamidol |
|
PMDSI No. 375 |
| Iopromide |
|
- |
| Iohexol (preparations with indications of cerebral angiography, angiocardiography (including pulmonary artery angiography), aortography, and angiocardiography of pediatrics (including pulmonary artery angiography)) |
|
- |
| Ioversol |
|
- |
| Iomeprol |
|
- |
June 25,
2020 |
Oxytocin |
|
(only in Japanese) |
- |
| Dinoprost |
|
- |
| Dinoprostone (oral dosage form) |
|
- |
Calonary L, Calonary M, Calonary H Infusion Solution
Hicaliq-1, Hicaliq-2, Hicaliq-3 Liquid
Hicaliq NC-L, Hicaliq NC-N, Hicaliq NC-H Infusion Solution
Rehabix-K1, Rehabix-K2 Infusion Solution |
|
The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
Amicaliq Infusion Solution
Paresafe Infusion Solution
Pareplus Infusion Solution |
|
- |
Amizet B Infusion Solution
Aminic Infusion Solution
Pleamin-P Injection, Hy-Pleamin Injection, Hy-Pleamin S Injection
Proteamin 12 Injection
Moriamin-S Injection
Moripron-F Infusion Solution |
|
- |
Amiparen Injection
Plas-amino Injection |
|
- |
Aminoleban Injection
Terufis Intravenous Drip Infusions
Hikarilevan Injection |
|
- |
Elneopa-NF No.1 Injection, Elneopa-NF No.2 Injection
Neoparen No.1 Injection, Neoparen No.2 Injection
Mixid L Injection, Mixid H Injection |
|
- |
Twinpal Infusion Solution
Bfluid Injection |
|
- |
Pntwin No.1, Pntwin No.2, Pntwin No.3 Infusion Solution
Fulcaliq 1, Fulcaliq 2, Fulcaliq 3 Infusion Solution
Onepal No.1, Onepal No.2 Infusion Solution |
|
- |
| Morihepamin Intravenous Drip Infusions |
|
- |
June 16,
2020 |
Memantine hydrochloride
Memantine hydrochloride |
|
|
PMDSI No. 374 |
Bevacizumab (genetical recombination)
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 1]
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 2] |
|
|
- |
June 1,
2020 |
Selexipag |
|
The Appendix for draft revisions is not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
| Clopidogrel sulfate |
|
- |
| Clopidogrel sulfate/aspirin |
|
- |
May 19,
2020 |
Insulin human (genetical recombination)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination) |
|
(only in Japanese) |
- |
| Insulin aspart (genetical recombination) |
|
- |
| Insulin glulisine (genetical recombination) |
|
- |
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1] |
|
- |
Insulin human (genetical recombination)
Insulin human (genetical recombination)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
Insulin detemir (genetical recombination)
Insulin glulisine (genetical recombination)
Insulin degludec (genetical recombination)
Insulin glargine (genetical recombination) [Insulin glargine biosimilar 1]
Insulin glargine (genetical recombination) [Insulin glargine biosimilar 2]
Insulin degludec (genetical recombination)/insulin aspart (genetical recombination) |
|
|
- |
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination)
Insulin lispro mix preparation 25
Insulin lispro mix preparation 50
Insulin degludec (genetical recombination)/liraglutide (genetical recombination)
Insulin glargine (genetical recombination)/lixisenatide
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1] |
|
- |
| Apalutamide |
|
|
PMDSI No. 373 |
| Fulvestrant |
|
|
- |
