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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018)

FY 2018 (No.352-)

Japanese version issued on No. Table of contents Posted on PDF
March 12,
2019
361
  1. Genome Research relating to Drug-induced Muscle Disorders
  2. Important Safety Information

1. Trastuzumab (genetical recombination) and other follow-on biologics
2. Nivolumab (genetical recombination)
3. Palbociclib
4. Pembrolizumab (genetical recombination)

  1. Revision of Precautions (No. 301)

    Eliglustat tartrate (and 5 others)

  1. List of Products Subject to Early Post-marketing Phase Vigilance
Mar 12,
2019
(Full text)
February 5,
2019
360
  1. Package Inserts of Prescription Drugs under the Revised Instructions
  2. Important Safety Information

1. Nusinersen sodium
2. Axitinib

  1. Revision of Precautions (No. 300)
    Nusinersen sodium (and 5 others)
  2. List of Products Subject to Early Post-marketing Phase Vigilance
Feb 5,
2019
(Full text)
December 25,
2018
359
  1. Safety of Influenza Antiviral Drugs
  2. Suspected Adverse Reactions to Influenza vaccines in the 2017 Season
  3. Important Safety Information

1. (1) Aluminum potassium sulfate hydrate/tannic acid (with saline)
    (2) Aluminum potassium sulfate hydrate/tannic acid (with analgesic agents)
2. Calcitriol (injectable dosage form)
3. Freeze-dried live attenuated varicella vaccine

  1. Revision of Precautions (No. 299)
    Aluminum potassium sulfate hydrate/tannic acid (with saline)(and 3 others)
  2. List of Products Subject to Early Post-marketing Phase Vigilance
Dec 25,
2018
(Full text)
Novmber 20,
2018
358
  1. Safety Measures for Influenza Antiviral Drugs
  2. Results of a Survey Investigating Access, Communication, and Utilization of Drug Safety Information at Hospitals and Pharmacies and Desirable Directions
  3. Important Safety Information

1. Secukinumab (genetical recombination)
2. Lamotrigine
3. Lenvatinib mesilate

  1. Revision of Precautions (No. 298)

(1) Atorvastatin calcium hydrate
(2) Ezetimibe/atorvastatin calcium hydrate
(3) Pravastatin sodium
(4) Amlodipine basilate/atorvastatin calcium hydrate (and 11 others)

  1. List of Products Subject to Early Post-marketing Phase Vigilance
Nov 20,
2018
(Full text)
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)