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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2015)

FY 2015 (No.322-331)
Japanese
version
issued
on
No. Table of contents Posted
on
PDF
March 15,
2016
331
  1. “Children and Medicines” Data Collecting Network Development Project
  2. Important Safety Information

(1)Eribulin mesilate

  1. Revision of Precautions (No. 272)

Methylphenidate hydrochloride (and 2 others)

  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2016)
March 15,
2016
(Summary)
March 24,
2016
(Full text)
February 9,
2016
330
  1. Preventative Measures for Accidental Ingestion of Pharmaceuticals by Children
  2. Important Safety Information

(1)Amlodipine besilate

(2)Itraconazole

  1. Revision of Precautions (No. 271)

Azilsartan(and 12 others)

  1. List of Products Subject toEarly Post-marketing Phase Vigilance (as of December 2015)
Feb 9,
2016
(Summary)
Feb 15,
2016
(Full text)
January 7,
2016
329
  1. Adverse Reaction to Influenza Vaccine in the 2014 Season
  2. Safety of Influenza Antiviral Drugs
  3. Important Safety Information

(1)Lenvatinib mesilate

  1. Revision of Precautions (No. 270)

Fomepizole (and 3 others)

  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2015)
(Reference)

Precautions Regarding Handling of Fire during Long-Term Oxygen Therapy (LOT)

Jan 7,
2016
(Summary)
Jan29,
2016
(Full text)
December 1,
2015
328
  1. Hypermagnesaemia caused by magnesium oxide
  2. Summary of the Relief System for Sufferers from Adverse Drug Reaction and Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs
  3. The Japan Drug Information Institute in Pregnancy
  4. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

  1. Revision of Precautions (No. 269)
     Galantamine hydrobromide (and 4 others)
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2015)
Dec 1,
2015
(Summary)
Dec 28,
2015
(Full text)
October 27,
2015
327
  1. Utilization of Blood Glucose Meters, etc. that Use Enzymatic Electrodes
  2. Precautions Concerning Recurrent and Similar Incidents of Medical Accidents
  3. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

(2)amantadine hydrochloride

(3)nivolumab (genetical recombination)

(4)sodium-glucose co-transporter 2 (SGLT2) inhibitors

  1. Revision of Precautions (No. 268)
      Fingolimod hydrochloride and azithromycin hydrate
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2015)
Oct 27,
2015
(Summary)
Dec 3,
2015
(Full text)
September 15,
2015
326
  1. Epidemiological Survey on Vaccination and Sudden Death of Infants
  2. Important Safety Information

(1)sterile talc

(2)panitumumab (genetical recombination)

  1. Revision of Precautions (No. 267)
   Hydroxyzine hydrochloride and hydroxyzine pamoate (and 4 others)
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2015)
Sep 15,
2015
(Summary)
Oct 13,
2015
(Full text)
August 6,
2015
325
  1. Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions
  2. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

(2)abiraterone acetate

(3)indapamide

(4)influenza HA vaccine

(5)interferon beta-1a (genetical recombination)

  1. Revision of Precautions (No. 266)
    Tramadol hydrochloride (OD tablets, capsules, and injections) and tramadol hydrochloride/acetaminophen (and 2 others)
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2015)
Aug 6,
2015
(Summary)
Sep 2,
2015
(Full text)
July 7,
2015
324
  1. Risk Management Plan
  2. Important Safety Information

(1)crizotinib
(2)technetium (99mTc) hydroxymethylenediphosphonate injection, kit for the preparation of technetium (99mTc) hydroxymethylenediphosphonate injection

  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of May 31, 2015)
July 7,
2015
(Summary)
July 29,
2015
(Full text)
May 26,
2015
323
  1. Utilization of New Bar Code Labeling and Termination of JAN/ITF Code Labeling on Prescription Drugs
  2. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

  1. Revision of Precautions (No. 265)
     Duloxetine hydrochloride (and 4 others)
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 30,2015)
May 26,
2015
(Summary)
July 3,
2015
(Full text)
April 28,
2015
322
  1. Adherence to the Cleaning and Disinfection Method to Prevent Transmission of Multidrug-resistant Bacteria by Duodenoscope
  2. Important Safety Information

(1)cyclophosphamide hydrate

(2)sitagliptin phosphate hydrate

(3)triamcinolone acetonide (intramuscular, intra-articular, and intradermal)

(4)pazopanib hydrochloride

(5)panitumumab (genetical recombination)

  1. Revision of Precautions (No. 264)
     Rebamipide (ophthalmic suspension) (and 2 others)
  1. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2015)
(Reference)

Precautions Concerning Recurrence and Similar Incidents of Medical Accidents

Apr 28,
2015
(Summary)
Jun 15,
2015
(Full text)

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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2015)
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