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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2017)

FY 2017 (No.342-)
Japanese
version
issued
on
No. Table of contents Posted
on
PDF
November 14,
2017
348
  1. Initiative of Revision of the Manuals for Management of Individual Serious Adverse Drug Reactions
  2. Prevention of Accidents with Electric Massagers for Household Use
  3. Important Safety Information

(1) Levetiracetam
(2) Linagliptin

  1. Revision of Precautions (No. 289)

Levetiracetam (and 8 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Nov 14, 2017 (Full text)
October 10,
2017
347
  1. Summary of the Relief System for Adverse Drug Reaction and Request of Cooperation for the System
  2. Important Safety Information

(1) Dabigatran etexilate methanesulfonate

  1. Revision of Precautions (No. 288)

Dabigatran etexilate methanesulfonate
(and 2 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Oct 10, 2017 (Full text)
September 5,
2017
346
  1. The Expert Committee on Quality of Generic Drug Products
  2. Introduction of the “My Drug List for Safety Updates” service
  1. Revision of Precautions (No. 287)

Riociguat (and 4 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Sep 5, 2017 (Full text)
August 1,
2017
345
  1. Summary of Guidance for Adverse Drug Reaction Reporting by Medical and Pharmaceutical Providers
  2. Important Safety Information

(1) Loxoprofen sodium hydrate (dermatologic preparation)
(2) Fluconazole, Fosfluconazole
(3) Nivolumab (genetical recombination)

  1. Revision of Precautions (No. 286)

Loxoprofen sodium hydrate
(dermatologic preparation)(and 16 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Aug 1, 2017 (Full text)
June 27,
2017
344
  1. Revision of Instructions for Package Inserts of Prescription Drugs
  2. Precautions Concerning Recurrent and Similar Medical Accidents
  3. Important Safety Information

(1) Treprostinil
(2) Bosutinib

  1. Revision of Precautions (No. 285)

Treprostinil (and 3 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
June 27,
2017
(Full text)
May 23,
2017
343
  1. Project of the Japan Drug Information Institute in Pregnancy
  1. Revision of Precautions (No. 284)

Denosumab (and 2 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
May 23,
2017
(Full text)
April 18,
2017
342
  1. Precautions for Dependence Associated with Hypnotics-Sedatives, Anxiolytics, and Antiepileptics
  2. Optimal Clinical Use Guidelines
  3. Important Safety Information

(1) Aluminum potassium sulfate hydrate/Tannic acid

  1. Revision of Precautions (No. 283)

Lamotrigine (and 37 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
April 19,
2017
(Full text)

 

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