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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2015)

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
PRECAUTIONS
[77.86 KB]
Investigation
[16.47 KB]
March 22,
2016
flunitrazepam (Injections) PRECAUTIONS
[42.41 KB]
Investigation
[18.38 KB]
loxoprofen sodium hydrate (Oral Solution)
loxoprofen sodium hydrate (Tablets, Fine Granules)
loxoprofen sodium hydrate (Tablets, Fine Granules)
PRECAUTIONS
[33.35 KB]
Investigation
[16.47 KB]
paliperidone palmitate PRECAUTIONS
[35.89 KB]
Investigation
[24.03 KB]
risperidone (Injections) PRECAUTIONS
[35.98 KB]
Investigation
[24.03 KB]
verteporfin PRECAUTIONS
[31.19 KB]
Investigation
[16.47 KB]
furosemide (Tablets)
furosemide (Tablets)
furosemide (Fine Granules)
furosemide (Extended-release dosage forms)
furosemide (Injections)
furosemide (Injections)
furosemide Kit
PRECAUTIONS
[37.67 KB]
Investigation
[21.58 KB]
mirabegron PRECAUTIONS
[37.83 KB]
Investigation
[17.93 KB]
 loxoprofen sodium hydrate
 (OTC drugs for oral use)
PRECAUTIONS
[38.22 KB]
Investigation
[15.04 KB]
February 16,
2016
methylphenidate hydrochloride
methylphenidate hydrochloride(Extended-release dosage forms)
PRECAUTIONS
[28.23 KB]
Investigation
[75.11 KB]
esomeprazole magnesium hydrate PRECAUTIONS
[30.09 KB]
Investigation
[36.79 KB]
eribulin mesilate PRECAUTIONS
[28.31 KB]
Investigation
[30.97 KB]
entecavir hydrate PRECAUTIONS
[30.06 KB]
Investigation
[30.57 KB]
January 12,
2016
azilsartan PRECAUTIONS
[37.03 KB]
Investigation
[30.57 KB]
azilsartan/amlodipine besilate PRECAUTIONS
[110.14 KB]
amlodipine besilate
amlodipine besilate
amlodipine besilate
amlodipine besilate
amlodipine besilate
PRECAUTIONS
[110.14 KB]
Investigation
[29.23 KB]
aliskiren fumarate/amlodipine besilate PRECAUTIONS
[41.50 KB]
Investigation
[29.23 KB]
irbesartan/amlodipine besilate PRECAUTIONS
[46.09 KB]
Investigation
[29.23 KB]
candesartan cilexetil/amlodipine besilate PRECAUTIONS
[42.74 KB]
Investigation
[29.23 KB]
telmisartan/amlodipine besilate PRECAUTIONS
[46.01 KB]
Investigation
[29.23 KB]
valsartan/amlodipine besilate
valsartan/amlodipine besilate
PRECAUTIONS
[37.98 KB]
Investigation
[29.23 KB]
amlodipine besilate/atorvastatin calcium hydrate PRECAUTIONS
[46.41 KB]
Investigation
[29.23 KB]
nintedanib ethanesulfonate PRECAUTIONS
[34.98 KB]
Investigation
[27.90 KB]
tazobactam/piperacillin hydrate(Injection)
tazobactam/piperacillin hydrate Kit
PRECAUTIONS
[41.33 KB]
Investigation
[115.16 KB]
piperacillin sodium(Injection)
piperacillin sodium Kit
PRECAUTIONS
[37.06 KB]
Investigation
[94.75 KB]
atovaquone PRECAUTIONS
[31.07 KB]
Investigation
[94.38 KB]
itraconazole(Capsules)
itraconazole(Tablets)
itraconazole(Oral Solution)
itraconazole(Injection)
PRECAUTIONS
[100.17 KB]
Investigation
[16.30 KB]
atovaquone/proguanil hydrochloride PRECAUTIONS
[36.76 KB]
Investigation
[94.38KB]
November 26,
2015
ombitasvir hydrate/paritaprevir hydrate/ritonavir PRECAUTIONS
[89.77 KB]
Investigation
[16.30 KB]
November 24,
2015
fomepizole PRECAUTIONS
[36.95 KB]
Investigation
[36.77 KB]
nivolumab (genetical recombination) PRECAUTIONS
[36.97 KB]
Investigation
[16.30 KB]
lenvatinib mesilate PRECAUTIONS
[84.94 KB]
Investigation
[18.49 KB]
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate PRECAUTIONS
[37.84 KB]
Investigation
[24.29 KB]
October 20,
2015
galantamine hydrobromide PRECAUTIONS
[35.42 KB]
Investigation
[21.66 KB]
magnesium oxide (Fine Granules)
magnesium oxide (Tablets)
magnesium oxide (Tablets)
magnesium oxide (Tablets)
magnesium oxide
PRECAUTIONS
[46.79 KB]
Investigation
[24.29 KB]
dutasteride (Benign prostatic hyperplasia)
dutasteride (Male pattern hair loss (androgenetic alopecia) in men only)
 
PRECAUTIONS
[37.16 KB]
Investigation
[23.44 KB]
ceftriaxone sodium hydrate (Injection)
ceftriaxone sodium hydrate Kit
PRECAUTIONS
[80.51 KB]
Investigation
[44.56 KB]
roxithromycin PRECAUTIONS
[41.14 KB]
Investigation
[58.03 KB]
asunaprevir
daclatasvir hydrochloride
PRECAUTIONS
[37.18 KB]
Investigation
[23.33 KB]
laxative drug containing magnesium oxide (Over the counter drugs) PRECAUTIONS
[35.47 KB]
Investigation
[58.03 KB]
September 15,
2015
amantadine hydrochloride PRECAUTIONS
[36.92 KB]
Investigation
[21.81 KB]
ipragliflozin L-proline
luseogliflozin hydrate
tofogliflozin hydrate
PRECAUTIONS
[44.85 KB]
Investigation
[23.42 KB]
canagliflozin hydrate
dapagliflozin propylene glycolate hydrate
empagliflozin
PRECAUTIONS
[47.24 KB]
Investigation
[23.42 KB]
fingolimod hydrochloride PRECAUTIONS
[36.98 KB]
Investigation
[23.45 KB]
nivolumab (genetical recombination) PRECAUTIONS
[41.27 KB]
Investigation
[28.67 KB]
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)
PRECAUTIONS
[38.07 KB]
Investigation
[30.92 KB]
asunaprevir
daclatasvir hydrochloride
PRECAUTIONS
[35.30 KB]
Investigation
[23.42 KB]
August 6,
2015
hydroxyzine hydrochloride (Tablets)
hydroxyzine hydrochloride (Injection)
hydroxyzine pamoate (Powder)
hydroxyzine pamoate (Tablets)
hydroxyzine pamoate (Capsules, Dry Syrup)
hydroxyzine pamoate (Syrup)
PRECAUTIONS
[35.26 KB]
Investigation
[35.51 KB]
memantine hydrochloride PRECAUTIONS
[30.10 KB]
Investigation
[32.02 KB]
deferasirox PRECAUTIONS
[23.10 KB]
Investigation
[33.76 KB]
sterile talc PRECAUTIONS
[23.56 KB]
Investigation
[53.71 KB]
panitumumab (genetical recombination) PRECAUTIONS
[23.03 KB]
Investigation
[32.03 KB]
pomalidomide PRECAUTIONS
[27.51 KB]
Investigation
[32.00 KB]
laninamivir octanoate hydrate
zanamivir hydrate
PRECAUTIONS
[23.15 KB]
Investigation
[16.41 KB]
July 7,
2015
tramadol hydrochloride (Injection)
tramadol hydrochloride (Capsules)
tramadol hydrochloride (Tablets (without controled release))
tramadol hydrochloride/acetaminophen
PRECAUTIONS
[22.00 KB]
Investigation
[18.85 KB]
indapamide PRECAUTIONS
[21.99 KB]
Investigation
[16.41 KB]
anagliptin PRECAUTIONS
[17.98 KB]
Investigation
[18.19 KB]
abiraterone acetate PRECAUTIONS
[17.74 KB]
Investigation
[18.03 KB]
asunaprevir
daclatasvir hydrochloride
PRECAUTIONS
[91.61 KB]
Investigation
[18.09 KB]
adefovir pivoxil PRECAUTIONS
[20.44 KB]
Investigation
[17.99 KB]
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)
PRECAUTIONS
[17.74 KB]
Investigation
[18.09 KB]
interferon beta-1a (genetical recombination)(Syringe)
interferon beta-1a (genetical recombination)(Pen)
PRECAUTIONS
[61.83 KB]
Investigation
[18.09 KB]
June 2,
2015
crizotinib PRECAUTIONS
[76.41 KB]
Investigation
[32.09 KB]
technetium(99mTc) hydroxymethylene-diphosphonate injection
kit for the preparation of technetium(99mTc) hydroxymethylene-diphosphonate injection
PRECAUTIONS
[34.90 KB]
Investigation
[31.95 KB]
April 23,
2015
duloxetine hydrochloride PRECAUTIONS
[42.69 KB]
Investigation
[32.02 KB]
azilsartan PRECAUTIONS
[76.41 KB]
Investigation
[31.95 KB]
clopidogrel sulfate(1)
clopidogrel sulfate(2)
PRECAUTIONS
[34.58 KB]
Investigation
[35.03 KB]
clopidogrel sulfate/aspirin PRECAUTIONS
[38.41 KB]
Investigation
[35.03 KB]
cefotaxime sodium PRECAUTIONS
[34.50 KB]
Investigation
[35.09 KB]
asunaprevir
daclatasvir hydrochloride
PRECAUTIONS
[34.36 KB]
Investigation
[32.54 KB]
April 8,
2015

April 2,
2015
(Originally Posted)
cetuximab (genetical recombination) PRECAUTIONS
[38.41 KB]
April 8, 2015
Investigation
[35.01 KB]
panitumumab (genetical recombination) PRECAUTIONS
[34.28 KB]
April 8, 2015
Investigation
[35.01 KB]