| 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 23,
2016
(March 29,2016 revised) |
Mycophenolate Mofetil
Mycophenolate Mofetil |
 |
|
March 22,
2016 |
flunitrazepam (Injections) |
|
|
loxoprofen sodium hydrate (Oral Solution)
loxoprofen sodium hydrate (Tablets, Fine Granules)
loxoprofen sodium hydrate (Tablets, Fine Granules) |
|
|
| paliperidone palmitate |
|
|
| risperidone (Injections) |
|
| verteporfin |
|
|
furosemide (Tablets)
furosemide (Tablets)
furosemide (Fine Granules)
furosemide (Extended-release dosage forms)
furosemide (Injections)
furosemide (Injections)
furosemide Kit |
|
|
| mirabegron |
|
|
loxoprofen sodium hydrate
(OTC drugs for oral use) |
|
|
February 16,
2016 |
methylphenidate hydrochloride
methylphenidate hydrochloride(Extended-release dosage forms) |
|
|
| esomeprazole magnesium hydrate |
|
|
| eribulin mesilate |
|
|
| entecavir hydrate |
|
|
January 12,
2016 |
azilsartan |
|
|
| azilsartan/amlodipine besilate |
|
|
amlodipine besilate
amlodipine besilate
amlodipine besilate
amlodipine besilate
amlodipine besilate |
|
| aliskiren fumarate/amlodipine besilate |
|
| irbesartan/amlodipine besilate |
|
| candesartan cilexetil/amlodipine besilate |
|
| telmisartan/amlodipine besilate |
|
valsartan/amlodipine besilate
valsartan/amlodipine besilate |
|
| amlodipine besilate/atorvastatin calcium hydrate |
|
| nintedanib ethanesulfonate |
|
|
tazobactam/piperacillin hydrate(Injection)
tazobactam/piperacillin hydrate Kit |
|
|
piperacillin sodium(Injection)
piperacillin sodium Kit |
|
|
| atovaquone |
|
|
itraconazole(Capsules)
itraconazole(Tablets)
itraconazole(Oral Solution)
itraconazole(Injection) |
|
|
| atovaquone/proguanil hydrochloride |
|
|
November 26,
2015 |
ombitasvir hydrate/paritaprevir hydrate/ritonavir |
|
|
November 24,
2015 |
fomepizole |
|
|
| nivolumab (genetical recombination) |
|
|
| lenvatinib mesilate |
|
|
| elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate |
|
|
October 20,
2015 |
galantamine hydrobromide |
|
|
magnesium oxide (Fine Granules)
magnesium oxide (Tablets)
magnesium oxide (Tablets)
magnesium oxide (Tablets)
magnesium oxide |
|
|
dutasteride (Benign prostatic hyperplasia)
dutasteride (Male pattern hair loss (androgenetic alopecia) in men only)
|
|
|
ceftriaxone sodium hydrate (Injection)
ceftriaxone sodium hydrate Kit |
|
|
| roxithromycin |
|
|
asunaprevir
daclatasvir hydrochloride |
|
|
| laxative drug containing magnesium oxide (Over the counter drugs) |
|
|
September 15,
2015 |
amantadine hydrochloride |
|
|
ipragliflozin L-proline
luseogliflozin hydrate
tofogliflozin hydrate |
|
|
canagliflozin hydrate
dapagliflozin propylene glycolate hydrate
empagliflozin |
|
| fingolimod hydrochloride |
|
|
| nivolumab (genetical recombination) |
|
|
azithromycin hydrate (Fine Granules)
azithromycin hydrate (250 mg, 500 mg Tablets)
azithromycin hydrate (600 mg Tablets)
azithromycin hydrate (Capsules)
azithromycin hydrate (Dry Syrup)
azithromycin hydrate (Injection) |
|
|
asunaprevir
daclatasvir hydrochloride |
|
|
August 6,
2015 |
hydroxyzine hydrochloride (Tablets)
hydroxyzine hydrochloride (Injection)
hydroxyzine pamoate (Powder)
hydroxyzine pamoate (Tablets)
hydroxyzine pamoate (Capsules, Dry Syrup)
hydroxyzine pamoate (Syrup) |
|
|
| memantine hydrochloride |
|
|
| deferasirox |
|
|
| sterile talc |
|
|
| panitumumab (genetical recombination) |
|
|
| pomalidomide |
|
|
laninamivir octanoate hydrate
zanamivir hydrate |
|
|
July 7,
2015 |
tramadol hydrochloride (Injection)
tramadol hydrochloride (Capsules)
tramadol hydrochloride (Tablets (without controled release))
tramadol hydrochloride/acetaminophen |
|
|
| indapamide |
|
|
| anagliptin |
|
|
| abiraterone acetate |
|
|
asunaprevir
daclatasvir hydrochloride |
|
|
| adefovir pivoxil |
|
|
influenza HA vaccine (1 mL, Vial)
influenza HA vaccine (0.5 mL, Vial)
influenza HA vaccine (0.5 mL, Syringe)
influenza HA vaccine (0.25 mL, Syringe) |
|
|
interferon beta-1a (genetical recombination)(Syringe)
interferon beta-1a (genetical recombination)(Pen) |
|
|
June 2,
2015 |
crizotinib |
|
|
technetium(99mTc) hydroxymethylene-diphosphonate injection
kit for the preparation of technetium(99mTc) hydroxymethylene-diphosphonate injection |
|
|
April 23,
2015 |
duloxetine hydrochloride |
|
|
| azilsartan |
|
|
clopidogrel sulfate(1)
clopidogrel sulfate(2) |
|
|
| clopidogrel sulfate/aspirin |
|
| cefotaxime sodium |
|
|
asunaprevir
daclatasvir hydrochloride |
|
|
April 8,
2015
April 2,
2015
(Originally Posted) |
cetuximab (genetical recombination) |
|
April 8, 2015
|
| panitumumab (genetical recombination) |
|
