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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018)

FY 2018 (No.352-)
Japanese version issued on No. Table of contents Posted on PDF
October 16,
2018
357
  1. Initiative of Revision of the Manuals for Management of Various Serious Adverse Drug Reactions (Part 2)
  2. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
  3. Revision of Precautions (No. 297)
    Amantadine hydrochloride (and 13 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Oct 16,
2018
(Full text)
September 4,
2018
356
  1. Guidance on Safe and Secure Radio Wave Utilization in Medical Institutions
  2. Important Safety Information

1. Ceftriaxone sodium hydrate

  1. Revision of Precautions (No. 296)

(1) Apremilast (and 1 other)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Sep 4,
2018
(Full text)
August 7,
2018
355
  1. Review of Contraindications for Immunosuppressants in Pregnant Women, etc.
  2. List of Products Subject to Early Post-marketing Phase Vigilance
(Reference)

Revision of the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance)

Aug 7,
2018
(Full text)
July 3,
2018
354
  1. Guidance of Appropriate Medication for Elderly Patients (general)
  2. Important Safety Information

1. Pegfilgrastim (genetical recombination)
2. Filgrastim (genetical recombination, follow on biologics)
3. Lenograstim (genetical recombination)

  1. Revision of Precautions (No. 295)
    (1) Amiodarone hydrochloride
    (and 4 others)
  2. List of Products Subject to
    Early Post-marketing Phase Vigilance
Jul 3,
2018
(Full text)
May 22,
2018
353
  1. Initiative for the Compilation of Database-stored Data and Provision of Information concerning Pediatric Drugs
  2. Important Safety Information

1. Pembrolizumab (genetical recombination)

  1. Revision of Precautions (No. 294)

(1) Omarigliptin
(2) Saxagliptin hydrate
(3) Trelagliptin succinate (and 3 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
May 22, 2018 (Full text)
April 17,
2018
352
  1. Introduction of the International Standards (ISO [IEC] 80369 series) Related to Connectors for Prevention of Interconnection
    - Switching of small-bore connectors for neuraxial anesthesia -
  2. Important Safety Information

(1) Tolvaptan
(2) Anagliptin, linagliptin, teneligliptin hydrobromide hydrate, teneligliptin hydrobromide hydrate/canagliflozin hydrate
(3) Anagliptin
(4) Sterile talc

  1. Revision of Precautions (No. 293)

Tolvaptan (and 5 others)

  1. List of Products Subject to
    Early Post-marketing Phase Vigilance
Apr 17, 2018 (Full text)

 

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