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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2014)

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 24,
2015
rebamipide (Ophthalmic solution) PRECAUTIONS
[38.19 KB]
Investigation
[32.07 KB]
triamcinolone acetonide (Intramuscular Injections and Intraarticular Injections)
triamcinolone acetonide (Intradermal Injections and Intraarticular Injections)
PRECAUTIONS
[34.59 KB]
Investigation
[63.55 KB]
sitagliptin phosphate hydrate PRECAUTIONS
[34.40 KB]
Investigation
[32.00 KB]
cyclophosphamide hydrate (Powders)
cyclophosphamide hydrate (Tablets)
cyclophosphamide hydrate (Injections)
PRECAUTIONS
[34.59 KB]
Investigation
[43.07 KB]
pazopanib hydrochloride PRECAUTIONS
[34.47 KB]
Investigation
[36.29 KB]
panitumumab (genetical recombination) PRECAUTIONS
[38.54 KB]
Investigation
[40.60 KB]
February 17,
2015
memantine hydrochloride PRECAUTIONS
[38.50 KB]
Investigation
[32.15 KB]
apixaban PRECAUTIONS
[38.82 KB]
Investigation
[40.60 KB]
montelukast sodium tablets(1)
montelukast sodium tablets(2)
montelukast sodium fine granule
PRECAUTIONS
[38.50 KB]
Investigation
[36.28 KB]
telaprevir PRECAUTIONS
[38.58 KB]
Investigation
[40.60 KB]
February 16,
2015
lamotrigine - Investigation
[43.48 KB]

BLUE LETTER
[156.61 KB]

Case Report
[124.13 KB]
February 2,
2015
abiraterone acetate PRECAUTIONS
[42.36 KB]
Investigation
[47.30 KB]
January 9,
2015
levetiracetam tablets
levetiracetam syrup
levetiracetam injection
PRECAUTIONS
[42.43 KB]
Investigation
[122.22 KB]
PRECAUTIONS
[42.36 KB]
Investigation
[128.84 KB]
tofogliflozin hydrate PRECAUTIONS
[43.20 KB]
Investigation
[128.84 KB]
tofogliflozin hydrate PRECAUTIONS
[43.20 KB]
Investigation
[117.89 KB]
linagliptin PRECAUTIONS
[42.36 KB]
Investigation
[117.27 KB]
amoxicillin hydrate fine granule
amoxicillin hydrate fine granule
amoxicillin hydrate tablets
amoxicillin hydrate capsules
potassium clavulanate/amoxicillin hydrat tablets
potassium clavulanate/amoxicillin hydrat syrup
lansoprazole/amoxicillin hydrate/clarithromycin
lansoprazole/amoxicillin hydrate/metronidazole
rabeprazole sodium/amoxicillin hydrate/clarithromycin
rabeprazole sodium/amoxicillin hydrate/metronidazole
PRECAUTIONS
[64.11 KB]
Investigation
[156.21 KB]
simeprevir sodium PRECAUTIONS
[42.30 KB]
Investigation
[120.67 KB]
freeze-dried live attenuated mumps virus vaccine PRECAUTIONS
[42.46 KB]
Investigation
[106.36 KB]
December 22,
2014
cabazitaxel acetonate PRECAUTIONS
[105.30 KB]
-
November 20,
2014
galantamine hydrobromide PRECAUTIONS
[53.49 KB]
Investigation
[199.08 KB]
November 19,
2014
simeprevir sodium - Investigation
[177.33 KB]

BLUE LETTER
[199.08 KB]

Case Report
[90.35 KB]
October 22,
2014
teneligliptin hydrobromide hydrate PRECAUTIONS
[41.64 KB]
Investigation
[55.32 KB]
enzalutamide PRECAUTIONS
[42.36 KB]
Investigation
[103.45 KB]
vancomycin hydrochloride (for oral use) PRECAUTIONS
[41.64 KB]
Investigation
[128.37 KB]
vancomycin hydrochloride (for injection) PRECAUTIONS
[43.45 KB]
Investigation
[128.37 KB]
acetaminophen
acetaminophen fine granule 
acetaminophen tablets
acetaminophen syrup 
acetaminophen syrup
acetaminophen injection
acetaminophen suppositorie
acetaminophen suppositorie
PRECAUTIONS
[41.64 KB]
-
September 16,
2014
pregabalin PRECAUTIONS
[38.78 KB]
Investigation
[117.13 KB]
imatinib mesilate PRECAUTIONS
[40.71 KB]
Investigation
[125.51 KB]
August 7,
2014
Pramipexole hydrochloride hydrate tablets(1)
Pramipexole hydrochloride hydrate SR tablets
PRECAUTIONS
[54.27 KB]
Investigation
[146.41 KB]
Tolvaptan PRECAUTIONS
[40.71 KB]
Investigation
[126.19 KB]
Carvedilol PRECAUTIONS
[46.88 KB]
Investigation
[126.37 KB]
Infliximab (genetical recombination) (including follow-on biologics/biosimilars) PRECAUTIONS
[46.94 KB]
Investigation
[128.35 KB]
Sugammadex sodium PRECAUTIONS
[47.58 KB]
Investigation
[122.96 KB]
Carboplatin PRECAUTIONS
[47.21 KB]
Investigation
[149.97 KB]
Doxycycline hydrochloride hydrate PRECAUTIONS
[47.81 KB]
Investigation
[117.11 KB]
Lansoprazole/Amoxicillin hydrate/Metronidazole
Rabeprazole sodium/Amoxicillin hydrate/Metronidazole
PRECAUTIONS
[47.11 KB]
Investigation
[149.97 KB]
Linezolid tablets
Linezolid injection
PRECAUTIONS
[60.01 KB]
Investigation
[127.80 KB]
Metronidazole (oral dosage form) PRECAUTIONS
[42.93 KB]
Investigation
[149.97 KB]
July 15,
2014

July 9,
2014
(Originally Posted)
Teriparatide (genetical recombination) July 15, 2014
PRECAUTIONS
[42.44 KB]
Investigation
[108.17 KB]
Inchinkoto (for ethical use) July 15, 2014
PRECAUTIONS
[42.93 KB]
Investigation
[104.66 KB]
Inchinkoto (OTC drugs) July 15, 2014
PRECAUTIONS
[43.02 KB]
Investigation
[115.97 KB]
Loratadine tablets(1)
Loratadine syrup
July 15, 2014
PRECAUTIONS
[42.16 KB]
Investigation
[108.87 KB]
Ibuprofen/Pseudoephedrine hydrochloride/Chlorpheniramine maleate/Dihydrocodeine phosphate/Caffeine anhydrous (OTC drugs)
Ibuprofen/Pseudoephedrine hydrochloride/L-Carbocisteine/d-Chlorpheniramine maleate/Dihydrocodeine phosphate/Caffeine anhydrous (OTC drugs)
July 15, 2014
PRECAUTIONS
[42.48 KB]
Investigation
[116.72 KB]
Simeprevir sodium July 15, 2014
PRECAUTIONS
[43.10 KB]
Investigation
[114.70 KB]
Amphotericin B [non-liposome preparation (injectable dosage form)] July 15, 2014
PRECAUTIONS
[42.48 KB]
Investigation
[110.03 KB]
Paroxetine hydrochloride hydrate tablets(1)
Paroxetine hydrochloride hydrate SR tablets
July 15, 2014
PRECAUTIONS
[89.09 KB]
Investigation
[42.60 KB]
June 10,
2014

June 4,
2014
(Originally Posted)
Azilsartan
Azilsartan/Amlodipine besilate
Irbesartan tablets
Irbesartan/Amlodipine besilate
Olmesartan medoxomil
Olmesartan medoxomil/Azelnidipine
Candesartan cilexetil tablets(1)
Valsartan tablets(1)
Valsartan tablets(2)
Valsartan/Amlodipine besilate
Valsartan/Cilnidipine
June 10, 2014
PRECAUTIONS
[47.51 KB]
Investigation
[126.55 KB]
Alacepril
Imidapril hydrochloride tablets
Imidapril hydrochloride tablets
Enalapril maleate tablets
Captopril fine granule
Captopril capsules
Quinapril hydrochloride
Cilazapril hydrate
Temocapril hydrochloride
Delapril hydrochloride
Trandolapril
Benazepril hydrochloride
Perindopril erbumine
Lisinopril hydrate
June 10, 2014
PRECAUTIONS
[48.51 KB]
Investigation
[126.55 KB]
Irbesartan/Trichlormethiazide June 10, 2014
PRECAUTIONS
[43.22 KB]
Investigation
[126.55 KB]
Candesartan cilexetil/Amlodipine besilate
Candesartan cilexetil/Hydrochlorothiazide
Valsartan/Hydrochlorothiazide
Losartan potassium/Hydrochlorothiazide
June 10, 2014
PRECAUTIONS
[47.98 KB]
Investigation
[126.55 KB]
Telmisartan
Telmisartan/Amlodipine besilate
June 10, 2014
PRECAUTIONS
[47.51 KB]
Investigation
[126.55 KB]
Telmisartan/Hydrochlorothiazide June 10, 2014
PRECAUTIONS
[42.64 KB]
Investigation
[126.55 KB]
Losartan potassium June 10, 2014
PRECAUTIONS
[44.99 KB]
Investigation
[126.55 KB]
Losartan potassium June 10, 2014
PRECAUTIONS
[42.64 KB]
Investigation
[63.98 KB]
Rosuvastatin calcium June 10, 2014
PRECAUTIONS
[42.90 KB]
Investigation
[134.84 KB]
Imidafenacin June 10, 2014
PRECAUTIONS
[42.64 KB]
Investigation
[113.95 KB]
Nartograstim (genetical recombination) June 10, 2014
PRECAUTIONS
[47.34 KB]
Investigation
[144.24 KB]
Filgrastim (genetical recombination)(including follow-on biologics/biosimilars)
Lenograstim (genetical recombination)
June 10, 2014
PRECAUTIONS
[47.16 KB]
Investigation
[144.24 KB]
April 24,
2014
Pentamidine Isetionate May 1,2014
PRECAUTIONS
[47.34 KB]
Investigation
[48.37 KB]
April 17,
2014
Paliperidone palmitate kit - BLUE LETTER
[205.70 KB]

Case Report
[147.21 KB]