Revisions of PRECAUTIONS (FY2014)

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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)
	triamcinolone acetonide (Intramuscular Injections and Intraarticular Injections)
	triamcinolone acetonide (Intradermal Injections and Intraarticular Injections)
	sitagliptin phosphate hydrate
	cyclophosphamide hydrate (Powders)
	cyclophosphamide hydrate (Tablets)
	cyclophosphamide hydrate (Injections)
	pazopanib hydrochloride
	panitumumab (genetical recombination)
February 17, 2015	memantine hydrochloride
	apixaban
	montelukast sodium tablets(1) montelukast sodium tablets(2) montelukast sodium fine granule
	telaprevir
February 16, 2015	lamotrigine	–	Investigation Results BLUE LETTER Case Report
February 2, 2015	abiraterone acetate
January 9, 2015	levetiracetam tablets levetiracetam syrup levetiracetam injection
	ipragliflozin L-proline empagliflozin canagliflozin hydrate dapagliflozin propylene glycolate hydrate luseogliflozin hydrate
	tofogliflozin hydrate
	tofogliflozin hydrate
	linagliptin
	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
	simeprevir sodium
	freeze-dried live attenuated mumps virus vaccine
December 22, 2014	cabazitaxel acetonate		–
November 20, 2014	galantamine hydrobromide
November 19, 2014	simeprevir sodium	–	Investigation Results BLUE LETTER Case Report
October 22, 2014	teneligliptin hydrobromide hydrate
	enzalutamide
	vancomycin hydrochloride (for oral use)
	vancomycin hydrochloride (for injection)
	acetaminophen acetaminophen fine granule acetaminophen tablets acetaminophen syrup acetaminophen syrup acetaminophen injection acetaminophen suppositorie acetaminophen suppositorie		–
September 16, 2014	pregabalin
September 16, 2014	imatinib mesilate
August 7, 2014	Pramipexole hydrochloride hydrate tablets(1) Pramipexole hydrochloride hydrate SR tablets
	Tolvaptan
	Carvedilol
	Infliximab (genetical recombination) (including follow-on biologics/biosimilars)
	Sugammadex sodium
	Carboplatin
	Doxycycline hydrochloride hydrate
	Lansoprazole/Amoxicillin hydrate/Metronidazole Rabeprazole sodium/Amoxicillin hydrate/Metronidazole
	Linezolid tablets Linezolid injection
	Metronidazole (oral dosage form)
July 15, 2014 July 9, 2014 (Originally Posted)	Teriparatide (genetical recombination)	July 15, 2014
	Inchinkoto (for ethical use)	July 15, 2014
	Inchinkoto (OTC drugs)	July 15, 2014
	Loratadine tablets(1) Loratadine syrup	July 15, 2014
	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
	Simeprevir sodium	July 15, 2014
	Amphotericin B [non-liposome preparation (injectable dosage form)]	July 15, 2014
	Paroxetine hydrochloride hydrate tablets(1) Paroxetine hydrochloride hydrate SR tablets	July 15, 2014
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
	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
	Irbesartan/Trichlormethiazide	June 10, 2014
	Candesartan cilexetil/Amlodipine besilate Candesartan cilexetil/Hydrochlorothiazide Valsartan/Hydrochlorothiazide Losartan potassium/Hydrochlorothiazide	June 10, 2014
	Telmisartan Telmisartan/Amlodipine besilate	June 10, 2014
	Telmisartan/Hydrochlorothiazide	June 10, 2014
	Losartan potassium	June 10, 2014
	Losartan potassium	June 10, 2014
	Rosuvastatin calcium	June 10, 2014
	Imidafenacin	June 10, 2014
	Nartograstim (genetical recombination)	June 10, 2014
	Filgrastim (genetical recombination)(including follow-on biologics/biosimilars) Lenograstim (genetical recombination)	June 10, 2014
April 24, 2014	Pentamidine Isetionate	May 1,2014
April 17, 2014	Paliperidone palmitate kit	–	BLUE LETTER Case Report

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Revisions of PRECAUTIONS (FY2014)

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